| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00809708075583 | HH-1R09-JP-JP | HH-1R09-JP-JP | CEM,CGA,CGZ,CHL,JFP,JGS,KHP | Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Speci Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Specific, Chloride,Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph,Electrode, Ion Specific, Calcium,Electrode, Ion Specific, Sodium,Acid, Lactic, Enzymatic Method | 1 | HOST 2, EPOC, JAPANESE, REFURBISHED | |
| 2 | 00809708047283 | CT-1004-00-00 | CT-1004-00-00 | CEM,CGA,CGZ,CHL,JFP,JGS,KHP | Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Speci Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Specific, Chloride,Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph,Electrode, Ion Specific, Calcium,Electrode, Ion Specific, Sodium,Acid, Lactic, Enzymatic Method | 1 | EPOC BGEM TEST CARD | |
| 3 | 00809708046521 | HH-0R03-XU-00 | EPOC HOST, INT'L, REFURB | |||||
| 4 | 00809708150310 | HH-1R10-CN-ZH | EPOC HOST 2, VETERINARY, CHINA, REFURBISHED | |||||
| 5 | 00809708150303 | HH-1010-CN-ZH | EPOC HOST 2, VETERINARY, CHINA | |||||
| 6 | 00809708055899 | HH-0010-JP-JP | HH-0010-JP-JP | CEM,CGA,CGZ,CHL,JFP,JGS,KHP | Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Speci Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Specific, Chloride,Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph,Electrode, Ion Specific, Calcium,Electrode, Ion Specific, Sodium,Acid, Lactic, Enzymatic Method | 1 | EPOC HOST, RX, JAPANESE | |
| 7 | 00809708051839 | HH-0R08-00-00 | EPOC HOST, RX, VET, NA, REFURB | |||||
| 8 | 00809708082734 | HH-1010-US-00 | EPOC HOST 2, VETERINARY, HESKA | |||||
| 9 | 00809708075606 | HH-1R10-JP-JP | HOST 2, EPOC, JAPANESE, VET, REFURBISHED | |||||
| 10 | 00809708032333 | HR-1R02-00-00 | HR-1R02-00-00 | CEM,CGA,CGZ,CHL,JFP,JGS,KHP | Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Speci Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Specific, Chloride,Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph,Electrode, Ion Specific, Calcium,Electrode, Ion Specific, Sodium,Acid, Lactic, Enzymatic Method | 1 | EPOC READER, REFURBISHED | |
| 11 | 00809708082819 | HR-1R03-US-00 | EPOC READER, VETERINARY, HESKA, REFURB | |||||
| 12 | 00809708016685 | HR-1002-00-00 | HR-1002-00-00 | EPOC READER | CEM,CGA,CGZ,CHL,JFP,JGS,KHP | Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Speci Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Specific, Chloride,Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph,Electrode, Ion Specific, Calcium,Electrode, Ion Specific, Sodium,Acid, Lactic, Enzymatic Method | 1 | EPOC READER |
| 13 | 00809708082741 | HH-1R10-US-00 | EPOC HOST 2, VETERINARY, HESKA, REFURB | |||||
| 14 | 00809708053918 | HH-1R10-00-00 | HOST 2, EPOC, VETERINARY, REFURBISHED | |||||
| 15 | 00630414606460 | 11413524 | 11413524 | The epoc Blood Analysis System, is intended for use by trained medical professio The epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for thequantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory orat the point of care in hospitals, nursing homes or other clinical care institutions. | JFP,CHL,CGA,GIO,KHP,JGS,CGZ,JFL,CEM | ELECTRODE, ION SPECIFIC, CALCIUM,Electrode measurement, blood-gases (pco2, po2) ELECTRODE, ION SPECIFIC, CALCIUM,Electrode measurement, blood-gases (pco2, po2) and blood ph,GLUCOSE OXIDASE, GLUCOSE,TUBE, COLLECTION, CAPILLARY BLOOD,ACID, LACTIC, ENZYMATIC METHOD,ELECTRODE, ION SPECIFIC, SODIUM,ELECTRODE, ION-SPECIFIC, CHLORIDE,pH rate measurement, carbon-dioxide,ELECTRODE, ION SPECIFIC, POTASSIUM | 1 | epoc Host2 |
| 16 | 00809708075590 | HH-1010-JP-JP | HOST 2, EPOC, JAPANESE, VETERINARY | |||||
| 17 | 00809708040659 | HR-1R03-00-00 | EPOC READER, VETERINARY, CE, REFURBISHED | |||||
| 18 | 00809708116712 | HR-1R04-00-00 | HR-1R04-00-00 | CHL,CEM,CGA,CGZ,JFP,JGS,KHP | Electrode measurement, blood-gases (pco2, po2) and blood ph,Electrode, Ion Speci Electrode measurement, blood-gases (pco2, po2) and blood ph,Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Specific, Chloride,Electrode, Ion Specific, Calcium,Electrode, Ion Specific, Sodium,Acid, Lactic, Enzymatic Method | 1 | EPOC READER, REFURBISHED, ROHS COMPLIANT | |
| 19 | 00809708097226 | HH-1R09-CN-ZH | HOST 2, EPOC, SIMPLIFIED CHINESE, REFURB | |||||
| 20 | 00809708064051 | HH-0R05-CA-00 | HH-0R05-CA-00 | CEM,CGA,CGZ,CHL,JFP,JGS,KHP | Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Speci Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Specific, Chloride,Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph,Electrode, Ion Specific, Calcium,Electrode, Ion Specific, Sodium,Acid, Lactic, Enzymatic Method | 1 | EPOC HOST, RX, CA, REFURBISHED | |
| 21 | 00809708064044 | HH-0005-CA-00 | HH-0005-CA-00 | CEM,CGA,CGZ,CHL,JFP,JGS,KHP | Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Speci Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Specific, Chloride,Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph,Electrode, Ion Specific, Calcium,Electrode, Ion Specific, Sodium,Acid, Lactic, Enzymatic Method | 1 | EPOC HOST, RX, CA | |
| 22 | 00809708055943 | HH-0R11-JP-JP | EPOC HOST, RX, VET, JAPANESE, REFURB | |||||
| 23 | 00809708053901 | HH-1R09-00-00 | HH-1R09-00-00 | CEM,CGA,CGZ,CHL,JFP,JGS,KHP | Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Speci Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Specific, Chloride,Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph,Electrode, Ion Specific, Calcium,Electrode, Ion Specific, Sodium,Acid, Lactic, Enzymatic Method | 1 | HOST 2, EPOC, REFURBISHED | |
| 24 | 00809708016678 | HH-0003-00-00 | HH-0003-00-00 | CEM,CGA,CGZ,CHL,JFP,JGS,KHP | Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Speci Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Specific, Chloride,Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph,Electrode, Ion Specific, Calcium,Electrode, Ion Specific, Sodium,Acid, Lactic, Enzymatic Method | 1 | EPOC HOST MOBILE COMPUTER | |
| 25 | 00809708075576 | HH-1009-JP-JP | HH-1009-JP-JP | CEM,CGA,CGZ,CHL,JFP,JGS,KHP | Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Speci Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Specific, Chloride,Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph,Electrode, Ion Specific, Calcium,Electrode, Ion Specific, Sodium,Acid, Lactic, Enzymatic Method | 1 | HOST 2, EPOC, JAPANESE | |
| 26 | 00809708040666 | HH-0R04-00-00 | EPOC HOST, VETERINARY, CE, REFURBISHED | |||||
| 27 | 00809708039417 | HR-1003-00-00 | EPOC READER, VETERINARY, CE | |||||
| 28 | 00809708114572 | SD-0004-00-00 | EDM LITE KIT | |||||
| 29 | 00809708061227 | HH-0R03-XU-JP | EPOC HOST, INT'L, JAPANESE, REFURBISHED | |||||
| 30 | 00809708049409 | HH-0R05-XU-00 | HH-0R05-XU-00 | CEM,CGA,CGZ,CHL,JFP,JGS,KHP | Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Speci Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Specific, Chloride,Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph,Electrode, Ion Specific, Calcium,Electrode, Ion Specific, Sodium,Acid, Lactic, Enzymatic Method | 1 | EPOC HOST, RX, INT'L, REFURB | |
| 31 | 00809708049386 | HH-0R05-00-00 | HH-0R05-00-00 | CEM,CGA,CGZ,CHL,JFP,JGS,KHP | Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Speci Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Specific, Chloride,Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph,Electrode, Ion Specific, Calcium,Electrode, Ion Specific, Sodium,Acid, Lactic, Enzymatic Method | 1 | EPOC HOST, RX, REFURB | |
| 32 | 00809708049379 | HH-0005-00-00 | HH-0005-00-00 | CEM,CGA,CGZ,CHL,JFP,JGS,KHP | Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Speci Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Specific, Chloride,Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph,Electrode, Ion Specific, Calcium,Electrode, Ion Specific, Sodium,Acid, Lactic, Enzymatic Method | 1 | EPOC HOST, RX | |
| 33 | 00809708049232 | AT-0007-00-00 | TUBE, CAPILLARY, VETERINARY, (BUNDLE 50) | |||||
| 34 | 00630414606095 | 11413475 | 16266 | The epoc Blood Analysis System, is intended for use by trained medical professio The epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for thequantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratoryor at the point of care in hospitals, nursing homes or other clinical care institutions. | KHP,CEM,CGZ,JGS,JFP,CHL,JFL,CGA | ACID, LACTIC, ENZYMATIC METHOD,ELECTRODE, ION SPECIFIC, POTASSIUM,ELECTRODE, ION ACID, LACTIC, ENZYMATIC METHOD,ELECTRODE, ION SPECIFIC, POTASSIUM,ELECTRODE, ION-SPECIFIC, CHLORIDE,ELECTRODE, ION SPECIFIC, SODIUM,ELECTRODE, ION SPECIFIC, CALCIUM,Electrode measurement, blood-gases (pco2, po2) and blood ph,pH rate measurement, carbon-dioxide,GLUCOSE OXIDASE, GLUCOSE | 1 | epoc NXS Host |
| 35 | 00809708046514 | HH-0003-XU-00 | EPOC HOST MOBILE COMPUTER, INT'L | |||||
| 36 | 00809708041137 | AT-0006-00-00 | AT-0006-00-00 | GIO | TUBE, COLLECTION, CAPILLARY BLOOD | 1 | CAPILLARY TUBE, CARE-FILL, BUNDLE OF 50 | |
| 37 | 00809708032340 | HH-0R03-00-00 | HH-0R03-00-00 | CEM,CGA,CGZ,CHL,JFP,JGS,KHP | Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Speci Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Specific, Chloride,Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph,Electrode, Ion Specific, Calcium,Electrode, Ion Specific, Sodium,Acid, Lactic, Enzymatic Method | 1 | EPOC HOST, REFURBISHED | |
| 38 | 00809708086145 | CT-1007-US-00 | EPOC BGEM CREA TEST CARD, VET, HESKA | |||||
| 39 | 00809708072254 | CT-1006-00-00 | CT-1006-00-00 | EPOC BGEM CREA TEST CARD | CEM,CGA,CGZ,CHL,JFP,JGS,KHP | Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Speci Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Specific, Chloride,Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph,Electrode, Ion Specific, Calcium,Electrode, Ion Specific, Sodium,Acid, Lactic, Enzymatic Method | 1 | EPOC BGEM CREA TEST CARD |
| 40 | 00809708069117 | HH-1009-CA-00 | HH-1009-CA-00 | CEM,CGA,CGZ,CHL,JFP,JGS,KHP | Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Speci Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Specific, Chloride,Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph,Electrode, Ion Specific, Calcium,Electrode, Ion Specific, Sodium,Acid, Lactic, Enzymatic Method | 1 | EPOC HOST 2, CA | |
| 41 | 00809708064068 | HH-0R03-CA-00 | HH-0R03-CA-00 | CEM,CGA,CGZ,CHL,JFP,JGS,KHP | Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Speci Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Specific, Chloride,Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph,Electrode, Ion Specific, Calcium,Electrode, Ion Specific, Sodium,Acid, Lactic, Enzymatic Method | 1 | EPOC HOST, CA, REFURBISHED | |
| 42 | 00809708052911 | HH-1010-00-00 | HOST 2, EPOC, VETERINARY | |||||
| 43 | 00809708052898 | HH-1009-00-00 | HH-1009-00-00 | CEM,CGA,CGZ,CHL,JFP,JGS,KHP | Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Speci Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Specific, Chloride,Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph,Electrode, Ion Specific, Calcium,Electrode, Ion Specific, Sodium,Acid, Lactic, Enzymatic Method | 1 | HOST 2, EPOC | |
| 44 | 00809708049423 | HH-0R07-00-00 | EPOC HOST, RX, VET, INT'L, REFURB | |||||
| 45 | 00809708047672 | CT-1005-00-00 | EPOC BGEM LAC TEST CARD, VET | |||||
| 46 | 00809708121860 | 10736515 | 10736515 | EPOC BGEM BUN TEST CARD | ||||
| 47 | 00809708097219 | HH-1009-CN-ZH | HH-1009-CN-ZH | CEM,CGA,CGZ,CHL,JFP,JGS,KHP | Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Speci Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Specific, Chloride,Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph,Electrode, Ion Specific, Calcium,Electrode, Ion Specific, Sodium,Acid, Lactic, Enzymatic Method | 1 | HOST 2, EPOC, SIMPLIFIED CHINESE | |
| 48 | 00809708071219 | CT-1007-00-00 | EPOC BGEM CREA TEST CARD, VETERINARY | |||||
| 49 | 00809708055905 | HH-0R10-JP-JP | EPOC HOST, RX, JAPANESE, REFURB | |||||
| 50 | 00809708049393 | HH-0005-XU-00 | HH-0005-XU-00 | CEM,CGA,CGZ,CHL,JFP,JGS,KHP | Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Speci Electrode, Ion Specific, Potassium,Glucose Oxidase, Glucose,Electrode, Ion-Specific, Chloride,Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph,Electrode, Ion Specific, Calcium,Electrode, Ion Specific, Sodium,Acid, Lactic, Enzymatic Method | 1 | EPOC HOST, RX, INT'L |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | EABA40000411 | 400-0041 | 400-0041 | The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is in The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, amylase, aspartate aminotransferase (AST), calcium, c-reactive protein (CRP), creatine kinase, creatinine, glucose, potassium, sodium, total bilirubin and blood urea nitrogen (BUN) in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement. | Piccolo AmLyte 13 | ABAXIS, INC. |
| 2 | EABA40000411 | 400-0041 | 400-0041 | The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is in The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, amylase, aspartate aminotransferase (AST), calcium, c-reactive protein (CRP), creatine kinase, creatinine, glucose, potassium, sodium, total bilirubin and blood urea nitrogen (BUN) in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement. | Piccolo AmLyte 13 | ABAXIS, INC. |
| 3 | EABA40000411 | 400-0041 | 400-0041 | The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is in The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, amylase, aspartate aminotransferase (AST), calcium, c-reactive protein (CRP), creatine kinase, creatinine, glucose, potassium, sodium, total bilirubin and blood urea nitrogen (BUN) in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement. | Piccolo AmLyte 13 | ABAXIS, INC. |
| 4 | EABA40000371 | 400-0037 | 400-0037 | The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemist The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, lactate, magnesium, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood or lithium heparinized plasma in a clinical laboratory setting or point-of-care location. | Piccolo MetLac 12 Panel | ABAXIS, INC. |
| 5 | EABA40000371 | 400-0037 | 400-0037 | The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemist The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, lactate, magnesium, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood or lithium heparinized plasma in a clinical laboratory setting or point-of-care location. | Piccolo MetLac 12 Panel | ABAXIS, INC. |
| 6 | EABA40000371 | 400-0037 | 400-0037 | The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemist The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, lactate, magnesium, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood or lithium heparinized plasma in a clinical laboratory setting or point-of-care location. | Piccolo MetLac 12 Panel | ABAXIS, INC. |
| 7 | EABA40000371 | 400-0037 | 400-0037 | The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemist The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, lactate, magnesium, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood or lithium heparinized plasma in a clinical laboratory setting or point-of-care location. | Piccolo MetLac 12 Panel | ABAXIS, INC. |
| 8 | EABA40000351 | 400-0035 | 400-0035 | The Piccolo® BioChemistry Panel Plus, used with the Piccolo Xpress® chemistry an The Piccolo® BioChemistry Panel Plus, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), c-reactive protein (CRP), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total protein, blood urea nitrogen (BUN), and uric acid in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement. | Piccolo BioChemistry Panel Plus | ABAXIS, INC. |
| 9 | EABA40000341 | 400-0034 | 400-0034 | The Piccolo® MetLyte Plus CRP reagent disc, used with the Piccolo Xpress® chemis The Piccolo® MetLyte Plus CRP reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of c-reactive protein (CRP), chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement. | Piccolo MetLyte Plus CRP | ABAXIS, INC. |
| 10 | EABA40000341 | 400-0034 | 400-0034 | The Piccolo® MetLyte Plus CRP reagent disc, used with the Piccolo Xpress® chemis The Piccolo® MetLyte Plus CRP reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of c-reactive protein (CRP), chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement. | Piccolo MetLyte Plus CRP | ABAXIS, INC. |
| 11 | EABA40000341 | 400-0034 | 400-0034 | The Piccolo® MetLyte Plus CRP reagent disc, used with the Piccolo Xpress® chemis The Piccolo® MetLyte Plus CRP reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of c-reactive protein (CRP), chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement. | Piccolo MetLyte Plus CRP | ABAXIS, INC. |
| 12 | EABA40000311 | 400-0031 | 400-0031 | The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry a The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry analyzer or Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, lactate dehydrogenase, magnesium, potassium, sodium, total carbon dioxide, and blood urea nitrogen in a clinical laboratory setting or point-of-care location. This disc is for testing heparinized plasma and serum, only. | Piccolo Basic Metabolic Panel Plus | ABAXIS, INC. |
| 13 | EABA40000311 | 400-0031 | 400-0031 | The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry a The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry analyzer or Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, lactate dehydrogenase, magnesium, potassium, sodium, total carbon dioxide, and blood urea nitrogen in a clinical laboratory setting or point-of-care location. This disc is for testing heparinized plasma and serum, only. | Piccolo Basic Metabolic Panel Plus | ABAXIS, INC. |
| 14 | EABA40000311 | 400-0031 | 400-0031 | The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry a The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry analyzer or Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, lactate dehydrogenase, magnesium, potassium, sodium, total carbon dioxide, and blood urea nitrogen in a clinical laboratory setting or point-of-care location. This disc is for testing heparinized plasma and serum, only. | Piccolo Basic Metabolic Panel Plus | ABAXIS, INC. |
| 15 | EABA40000301 | 400-0030 | 400-0030 | The Piccolo® Lipid Panel Plus, used with the Piccolo® blood chemistry analyzer o The Piccolo® Lipid Panel Plus, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended for the in vitro quantitative determination of total cholesterol (CHOL), high-density lipoprotein cholesterol (HDL), triglycerides (TRIG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and glucose (GLU) in capillary (fingerstick) lithium heparinized whole blood, venous lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. From the CHOL, HDL and TRIG determinations, low-density lipoprotein cholesterol (LDL), very low-density lipoprotein cholesterol (VLDL), non-HDL cholesterol, and a total cholesterol/high-density lipoprotein cholesterol ratio (TC/H) are calculated by the analyzer.Lipid measurements are used in the diagnosis and treatment of lipid and lipoprotein disorders, atherosclerosis, various liver and renal diseases, diabetes mellitus, and other diseases involving lipid metabolism or various endocrine disorders.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood (venous or capillary) may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo Lipid Panel Plus | ABAXIS, INC. |
| 16 | EABA40000291 | 400-0029 | 400-0029 | The Piccolo® General Chemistry 13 used with the Piccolo blood chemistry analyzer The Piccolo® General Chemistry 13 used with the Piccolo blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total bilirubin, total protein, blood urea nitrogen (BUN), and uric acid in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo General Chemistry 13 | ABAXIS, INC. |
| 17 | EABA40000281 | 400-0028 | 400-0028 | The Piccolo® Comprehensive Metabolic Panel, used with the Piccolo® blood chemist The Piccolo® Comprehensive Metabolic Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo Comprehensive Metabolic Panel | ABAXIS, INC. |
| 18 | EABA40000281 | 400-0028 | 400-0028 | The Piccolo® Comprehensive Metabolic Panel, used with the Piccolo® blood chemist The Piccolo® Comprehensive Metabolic Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo Comprehensive Metabolic Panel | ABAXIS, INC. |
| 19 | EABA40000281 | 400-0028 | 400-0028 | The Piccolo® Comprehensive Metabolic Panel, used with the Piccolo® blood chemist The Piccolo® Comprehensive Metabolic Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo Comprehensive Metabolic Panel | ABAXIS, INC. |
| 20 | EABA40000271 | 400-0027 | 400-0027 | The Piccolo® Renal Function Panel, used with the Piccolo® blood chemistry analyz The Piccolo® Renal Function Panel, used with the Piccolo® blood chemistry analyzer or the PiccoloXpress® chemistry analyzer is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo Renal Function Panel | ABAXIS, INC. |
| 21 | EABA40000271 | 400-0027 | 400-0027 | The Piccolo® Renal Function Panel, used with the Piccolo® blood chemistry analyz The Piccolo® Renal Function Panel, used with the Piccolo® blood chemistry analyzer or the PiccoloXpress® chemistry analyzer is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo Renal Function Panel | ABAXIS, INC. |
| 22 | EABA40000271 | 400-0027 | 400-0027 | The Piccolo® Renal Function Panel, used with the Piccolo® blood chemistry analyz The Piccolo® Renal Function Panel, used with the Piccolo® blood chemistry analyzer or the PiccoloXpress® chemistry analyzer is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo Renal Function Panel | ABAXIS, INC. |
| 23 | EABA40000241 | 400-0024 | 400-0024 | The Piccolo® Basic Metabolic Panel, used with the Piccolo blood chemistry analyz The Piccolo® Basic Metabolic Panel, used with the Piccolo blood chemistry analyzer or the PiccoloXpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, potassium, sodium, total carbon dioxide, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo Basic Metabolic Panel | ABAXIS, INC. |
| 24 | EABA40000241 | 400-0024 | 400-0024 | The Piccolo® Basic Metabolic Panel, used with the Piccolo blood chemistry analyz The Piccolo® Basic Metabolic Panel, used with the Piccolo blood chemistry analyzer or the PiccoloXpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, potassium, sodium, total carbon dioxide, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo Basic Metabolic Panel | ABAXIS, INC. |
| 25 | EABA40000241 | 400-0024 | 400-0024 | The Piccolo® Basic Metabolic Panel, used with the Piccolo blood chemistry analyz The Piccolo® Basic Metabolic Panel, used with the Piccolo blood chemistry analyzer or the PiccoloXpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, potassium, sodium, total carbon dioxide, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo Basic Metabolic Panel | ABAXIS, INC. |
| 26 | EABA40000231 | 400-0023 | 400-0023 | The Piccolo® MetLyte 8 Panel, used with the Piccolo® blood chemistry analyzer or The Piccolo® MetLyte 8 Panel, used with the Piccolo® blood chemistry analyzer or the PiccoloXpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo MetLyte 8 Panel | ABAXIS, INC. |
| 27 | EABA40000231 | 400-0023 | 400-0023 | The Piccolo® MetLyte 8 Panel, used with the Piccolo® blood chemistry analyzer or The Piccolo® MetLyte 8 Panel, used with the Piccolo® blood chemistry analyzer or the PiccoloXpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo MetLyte 8 Panel | ABAXIS, INC. |
| 28 | EABA40000231 | 400-0023 | 400-0023 | The Piccolo® MetLyte 8 Panel, used with the Piccolo® blood chemistry analyzer or The Piccolo® MetLyte 8 Panel, used with the Piccolo® blood chemistry analyzer or the PiccoloXpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo MetLyte 8 Panel | ABAXIS, INC. |
| 29 | EABA40000221 | 400-0022 | 400-0022 | The Piccolo® Electrolyte Panel, used with the Piccolo® blood chemistry analyzer The Piccolo® Electrolyte Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of chloride, potassium, sodium, and total carbon dioxide in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo Electrolyte Panel | ABAXIS, INC. |
| 30 | EABA40000221 | 400-0022 | 400-0022 | The Piccolo® Electrolyte Panel, used with the Piccolo® blood chemistry analyzer The Piccolo® Electrolyte Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of chloride, potassium, sodium, and total carbon dioxide in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo Electrolyte Panel | ABAXIS, INC. |
| 31 | EABA40000061 | 400-0006 | 400-0006 | The Piccolo® General Chemistry 6 , used with the Piccolo® blood chemistry analyz The Piccolo® General Chemistry 6 , used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, gamma glutamyltransferase (GGT), glucose, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo General Chemistry 6 | ABAXIS, INC. |
| 32 | 00887473000160 | 01GS11 | SD GlucoNavii Blood Glucose Test Strip | SD BIOSENSOR, INC. | ||
| 33 | 00887473000139 | 01GCS10 | SD Glucose Control Solution | SD BIOSENSOR, INC. | ||
| 34 | 00887473000122 | 01GS11C | SD GlucoNavii Blood Glucose Test Strip | SD BIOSENSOR, INC. | ||
| 35 | 00887473000108 | 01GC110 | SD GlucoNavii Blood Glucose Monitoring System | SD BIOSENSOR, INC. | ||
| 36 | 00887473000016 | 01GM11 | SD GlucoNavii Blood Glucose Monitoring System | SD BIOSENSOR, INC. | ||
| 37 | 00887473000009 | 01GC111 | SD GlucoNavii Blood Glucose Monitoring System | SD BIOSENSOR, INC. | ||
| 38 | 00885502001041 | IGM-0009 | IGM-G3-103 | Control™ Meter Kit | U.S. DIAGNOSTICS INC. | |
| 39 | 00885502001034 | IGM-0008 | IGM-G2-103 | EasyGluco™G2 Meter Kit | U.S. DIAGNOSTICS INC. | |
| 40 | 00885502001003 | IGM-0024 | G5-103MK | INFINITY™ Meter Kit | U.S. DIAGNOSTICS INC. | |
| 41 | 00885502000044 | IGM-0009 | IGM-G3-003 | Control™ Starter Kit | U.S. DIAGNOSTICS INC. | |
| 42 | 00885502000037 | IGM-0008 | IGM-G2-101 | EasyGluco™G2 Starter Kit | U.S. DIAGNOSTICS INC. | |
| 43 | 00885502000006 | IGM-0024 | G5-003SK | INFINITY™ Starter Kit | U.S. DIAGNOSTICS INC. | |
| 44 | 00885325001426 | 343105 | Tempo Blood Glucose Test Strip | Tempo | I-SENS, INC. | |
| 45 | 00885325001419 | 343104 | Tempo Blood Glucose Test Strip | Tempo | I-SENS, INC. | |
| 46 | 00885325001327 | 164307 | CareSens N Blood Glucose Monitoring System | CareSens N | I-SENS, INC. | |
| 47 | 00885325001310 | 164284 | CareSens N Blood Glucose Monitoring System | CareSens N | I-SENS, INC. | |
| 48 | 00885325001242 | 164101 | CareSens N Blood Glucose Test Strip | CareSens N | I-SENS, INC. | |
| 49 | 00885325001105 | 164303-203 | CareSens N Blood Glucose Monitoring System (White) | CareSens N | I-SENS, INC. | |
| 50 | 00885325000818 | 520010 | COOL Blood Glucose Test Strip | COOL | I-SENS, INC. |