No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 05060500092030 | IR960-DAU | IR960-DAU | Multi-Analyte DAU Control Kit 4 X 15 mL | DIF | Drug Mixture Control Materials | 1 | Synermed® |
2 | 05060500092023 | IR952-DAU | IR952-DAU | Multi-Analyte DAU Calibrator Kit 4 X 15 mL | DKB | Calibrators, Drug Mixture | 2 | Synermed® |
3 | 05060500092016 | VI114-1200 | VI114-1200 | Sodium Reagent 2 X 66 mL + 1 X 66 mL | MZU | System,Test,Sodium,Enzymatic Method | 2 | Synermed® |
4 | 05060500092009 | VI113-1200 | VI113-1200 | Potassium Reagent 2 X 66 mL + 1 X 33 mL | MZV | Test,System,Potassium,Enzymatic Method | 2 | Synermed® |
5 | 05060500091996 | IR059-1200 | IR059-1200 | LDL-Cholesterol Reagent 2 X 66 mL + 1 X 44 mL | LBR | Ldl & Vldl Precipitation, Hdl | 1 | Synermed® |
6 | 05060500091989 | IR056-1200 | IR056-1200 | HDL-Cholesterol Reagent 2 X 66 mL + 1 X 44 mL | LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | Synermed® |
7 | 05060500091972 | IR460-1200 | IR460-1200 | Uric Acid Reagent 2 X 67 mL + 1 X 54 mL | KNK | Acid, Uric, Uricase (Colorimetric) | 1 | Synermed® |
8 | 05060500091965 | IR150-1200 | IR150-1200 | UIBC Reagent 2 X 66 mL + 2 X 1 mL + 1 X 44 mL | JMO | Ferrozine (Colorimetric) Iron Binding Capacity | 1 | Synermed® |
9 | 05060500091958 | IR140-1200 | IR140-1200 | Triglycerides Reagent 8 X 67 mL + 8 wedges | CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | Synermed® |
10 | 05060500091941 | VI530-1200 | VI530-1200 | Total Protein Reagent 6 X 67 mL + 3 X 67 mL | CEK | Biuret (Colorimetric), Total Protein | 2 | Synermed® |
11 | 05060500091934 | IR110-1200 | IR110-1200 | Phosphorus Reagent 2 X 67 mL + 1 X 54 mL | CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | Synermed® |
12 | 05060500091927 | IR170-1200 | IR170-1200 | Magnesium Reagent 4 X 67 mL | JGJ | Photometric Method, Magnesium | 1 | Synermed® |
13 | 05060500091910 | UV340-1200 | UV340-1200 | LDH Reagent 2 X 67 mL + 1 X 54 mL | CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 | Synermed® |
14 | 05060500091903 | IR320-1200 | IR320-1200 | Serum Iron Reagent 2 X 67 mL + 1 X 44 mL | CFM | Bathophenanthroline, Colorimetry, Iron (Non-Heme) | 1 | Synermed® |
15 | 05060500091897 | IR070-1200 | IR070-1200 | Glucose Reagent 6 X 67 mL + 3 X 54 mL | CGA | Glucose Oxidase, Glucose | 2 | Synermed® |
16 | 05060500091880 | VI410-1200 | VI410-1200 | GGT Reagent 3 X 67 mL + 3 wedges | JQB | Kinetic Method, Gamma-Glutamyl Transpeptidase | 1 | Synermed® |
17 | 05060500091873 | VI560-1200 | VI560-1200 | Creatinine Reagent 4 X 67 mL + 4 X 67 mL | CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 | Synermed® |
18 | 05060500091866 | UV310-1200 | UV310-1200 | Creatine Kinase Reagent 2 X 60 mL + 1 X 60 mL + 3 wedges | CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 2 | Synermed® |
19 | 05060500091859 | IR060-1200 | IR060-1200 | Cholesterol Reagent 6 X 67 mL + 3 X 54 mL | CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | Synermed® |
20 | 05060500091842 | IR050-1200 | IR050-1200 | Chloride Reagent 3 X 67 mL | CHG | Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride | 2 | Synermed® |
21 | 05060500091835 | IR240-1200 | IR240-1200 | Calcium Reagent 8 X 67 mL | CJY | Azo Dye, Calcium | 2 | Synermed® |
22 | 05060500091828 | IR700-1200 | IR700-1200 | Total Bilirubin Reagent 8 X 67 mL | CIG | Diazo Colorimetry, Bilirubin | 2 | Synermed® |
23 | 05060500091811 | IR750-1200 | IR750-1200 | Direct Bilirubin Reagent 2 X 67 mL | CIG | Diazo Colorimetry, Bilirubin | 2 | Synermed® |
24 | 05060500091804 | UV193-L | UV193-L | Urea Nitrogen (BUN) Reagent 6 X 500 mL | CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 | Synermed® |
25 | 05060500091798 | UV192-L | UV192-L | Urea Nitrogen (BUN) Enzyme Reagent 6 X 500 mL | CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 | Synermed® |
26 | 05060500091781 | UV191-L | UV191-L | Urea Nitrogen (BUN) Coenzyme Reagent 6 X 500 mL | CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 | Synermed® |
27 | 05060500091774 | UV190-911 | UV190-911 | Urea Nitrogen (BUN) Reagent 6 X 50 mL + 3 X 50 mL | CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 | Synermed® |
28 | 05060500091767 | UV190-WK | UV190-WK | Urea Nitrogen (BUN) Reagent 4 X 25 mL + 4 X 12.5 mL | CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 | Synermed® |
29 | 05060500091750 | UV190-X | UV190-X | Urea Nitrogen (BUN) Reagent 1 X 200 mL + 1 X 100 mL | CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 | Synermed® |
30 | 05060500091743 | UV190-R | UV190-R | Urea Nitrogen (BUN) Reagent 3 X 200 mL + 3 X 100 mL | CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 | Synermed® |
31 | 05060500091736 | UV190-1200 | UV190-1200 | Urea Nitrogen (BUN) Reagent 6 X 67 mL + 3 X 67 mL | CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 | Synermed® |
32 | 05060500091729 | UV085-1200 | UV085-1200 | AST Reagent 8 X 67 mL + 2 X 67 mL | CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 2 | Synermed® |
33 | 05060500091712 | UV185-1200 | UV185-1200 | ALT Reagent 8 X 67 mL + 2 X 67 mL | CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 | Synermed® |
34 | 05060500091705 | VI400-1200 | VI400-1200 | Amylase Reagent 2 X 67 mL | JFJ | Catalytic Methods, Amylase | 2 | Synermed® |
35 | 05060500091699 | VI120-1200 | VI120-1200 | AMP Alkaline Phosphatase Reagent 6 X 67mL + 6 powder wedges | CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 2 | Synermed® |
36 | 05060500091682 | IR010-1200 | IR010-1200 | Albumin Reagent 8 X 67 mL | CIX | Bromcresol Green Dye-Binding, Albumin | 2 | Synermed® |
37 | 05060500091675 | 0858 | 0858 | Drugs of Abuse Level 2 Control 1 X 15 mL | DIF | Drug Mixture Control Materials | 1 | Synermed® |
38 | 05060500091668 | 0857 | 0857 | Drugs of Abuse Level 1 Control 1 X 15 mL | DIF | Drug Mixture Control Materials | 1 | Synermed® |
39 | 05060500091651 | 0855 | 0855 | Drugs of Abuse High Calibrator 1 X 15 mL | DKB | Calibrators, Drug Mixture | 2 | Synermed® |
40 | 05060500091644 | 0854 | 0854 | Drugs of Abuse Intermediate Calibrator 1 X 15 mL | DKB | Calibrators, Drug Mixture | 2 | Synermed® |
41 | 05060500091637 | 0853 | 0853 | Drugs of Abuse Cutoff Calibrator 1 X 15 mL | DKB | Calibrators, Drug Mixture | 2 | Synermed® |
42 | 05060500091620 | 0852 | 0852 | Drugs of Abuse Low Calibrator 1 X 15 mL | DKB | Calibrators, Drug Mixture | 2 | Synermed® |
43 | 05060500091613 | 001 | 001 | Drugs of Abuse Negative Calibrator 1 X 15 mL | DKB | Calibrators, Drug Mixture | 2 | Synermed® |
44 | 05060500091606 | IR952-ETOH | IR952-ETOH | Alcohol Standards and Controls 6 X 25 mL | JIX | Calibrator, Multi-Analyte Mixture | 2 | Synermed® |
45 | 05060500091590 | ISE530-K | ISE530-K | ISE Calibrators and Controls 12 X 15 mL | JIX | Calibrator, Multi-Analyte Mixture | 2 | Synermed® |
46 | 05060500091576 | IR960-CO2 | IR960-CO2 | CO2 Controls 12 X 15 mL | JIX | Calibrator, Multi-Analyte Mixture | 2 | Synermed® |
47 | 05060500091569 | IR952-CO2 | IR952-CO2 | CO2 Calibrators 12 X 15 mL | JIX | Calibrator, Multi-Analyte Mixture | 2 | Synermed® |
48 | 05060500091552 | IR962-X | IR962-X | Affirm 2 Multi Analyt High Control 12 X 5 mL (reconstituted) | JIX | Calibrator, Multi-Analyte Mixture | 2 | Synermed® |
49 | 05060500091545 | IR961-X | IR961-X | Affirm 1 Multi Analyt Low Control 12 X 5 mL (reconstituted) | JIX | Calibrator, Multi-Analyte Mixture | 2 | Synermed® |
50 | 05060500091538 | IR954 | IR954 | IRCal II Multi Analyt Calibrator 12 X 5 mL (reconstituted) | JIX | Calibrator, Multi-Analyte Mixture | 2 | Synermed® |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00817302023091 | DT251 | DT251 | CA (Calcium) 4 x 300 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CA REAGENT PRODUCT NO. DT251 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
2 | 00817302020441 | 88815 | 88815 | CA3 (Calcium) - CX3 Reagent 1 x 1000 mL | CAROLINA LIQUID CHEMISTRIES CORP.™ CALCIUM REAGENT 88815 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
3 | 00817302020434 | CC251 | CC251 | CA (Calcium) 2 x 300 tests | CAROLINA LIQUID CHEMISTRIES CORP.™ CA CALCIUM REAGENT CC251 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
4 | 00817302020427 | AU-251 | AU-251 | CA (Calcium) 3 x 300 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CA RGT. KIT AU-251 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
5 | 00817302020410 | BL251 | BL251 | CA (Calcium) 3 x 160 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CA RGT. KIT BL-251 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
6 | 00817302020403 | ST251 | ST251 | CA (Calcium) 4 x 200 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 CA RGT KIT Product No. ST251 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
7 | 00817274022450 | CAA2-1L | CAA2-1L | Calcium Arsenazo Reagent(1 x 1L) | JAS Diagnostics | DREW SCIENTIFIC, INC. |
8 | 00817274021071 | CAA2-BUL | CALCIUM ARSENAZO BULK LIQUID | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
9 | 00817274021064 | XL-CAA2-40 | CALCIUM ARSENAZO (5 X 40mL) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
10 | 00817274021057 | XL-CAA2-40 | CALCIUM ARSENAZO (5 x 40mL) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
11 | 00817274021040 | CAA2-125 | CALCIUM ARSENAZO (2x 125mL | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
12 | 00657498001462 | S0155-750 | S0155-750 | For the Quantitative Colorimetric Determination of Total Calcium in Serum and Plasma. | Sirrus® Calcium LiquiColor® | STANBIO LABORATORY, L.P. |
13 | 00657498000618 | 0155-225 | 0155-225 | For the Quantitative Colorimetric determination of Total Calcium in serum. | Calcium (Arsenazo) LiquiColor® | STANBIO LABORATORY, L.P. |
14 | 00630414553160 | 10283344 | 6860493 | Calcium - ADVIA Chem. - RGT - 4x1700 tests | ADVIA® Chemistry CA_2c Calcium_2 Reagents, Concentrated - Arsenazo III | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
15 | 00630414513102 | 10341116 | 2189915 | Calcium - ADVIA Chem. - RGT - 7x290/7x230 tests | ADVIA® Chemistry CA_2 Calcium_2 Reagents (Arsenazo III) | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
16 | 00630414513096 | 10316612 | 2189699 | Calcium - ADVIA Chem. - RGT - 8x550/8x430 tests | ADVIA® Chemistry CA_2 Calcium Reagents (Arsenazo III) | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
17 | 00630414220697 | 11097644 | 11097644 | Calcium_2 (CA_2) Atellica CH - RGT 8200T | Atellica CH CA_2 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
18 | 00628063400270 | SK140-10 | SK140-10 | CALCIUM | SEKISUI DIAGNOSTICS, LLC | |
19 | 00628063400263 | 140-24 | 140-24 | CALCIUM Assay | SEKISUI DIAGNOSTICS, LLC | |
20 | 00628063400256 | 140-20 | 140-20 | CALCIUM Assay | SEKISUI DIAGNOSTICS, LLC | |
21 | 00386100002060 | 10210-4 | 10210-4 | Calcium Reagent Kit for use with EasyRA Analyzers | Ca Reagent Kit | MEDICA CORPORATION |
22 | 00380740161514 | 3L79-42 | 03L7942 | Calcium | ARCHITECT | ABBOTT GMBH |
23 | 00380740161507 | 3L79-32 | 03L7932 | Calcium | ARCHITECT | ABBOTT GMBH |
24 | 00380740161491 | 3L79-22 | 03L7922 | Calcium | ARCHITECT | ABBOTT GMBH |
25 | 00380740135409 | 07P5730 | 07P5730 | Alinity c Calcium Reagent Kit 15000 Tests | Alinity | ABBOTT GMBH |
26 | 00380740132613 | 07P5720 | 07P5720 | Alinity c Calcium Reagent Kit 4000 Tests | Alinity | ABBOTT GMBH |
27 | 00380740005948 | 3L79-31 | 03L7931 | Calcium | ARCHITECT | ABBOTT LABORATORIES |
28 | 00380740005931 | 3L79-21 | 03L7921 | Calcium | ARCHITECT | ABBOTT LABORATORIES |
29 | 15099590060183 | OSR66117 | Calcium Arsenazo | AU | BECKMAN COULTER, INC. | |
30 | 15099590011086 | OSR61117 | Calcium Arsenazo | AU | BECKMAN COULTER, INC. | |
31 | 15099590000325 | OSR60117 | Calcium Arsenazo | AU | BECKMAN COULTER, INC. | |
32 | 10758750031795 | 6844295 | 6844295 | VITROS XT Chemistry Products GLU-Ca Slides | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
33 | 10758750009114 | 1450261 | 1450261 | VITROS Chemistry Products Ca Slides | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
34 | 05060500091835 | IR240-1200 | IR240-1200 | Calcium Reagent 8 X 67 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
35 | 05060500090500 | IR240-L | IR240-L | Calcium Reagent 6 X 1000 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
36 | 05060500090494 | IR240-911 | IR240-911 | Calcium Reagent 8 X 250 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
37 | 05060500090487 | IR240-WK | IR240-WK | Calcium Reagent 4 X 55 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
38 | 05060500090470 | IR240-X | IR240-X | Calcium Reagent 2 X 250 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
39 | 05060500090463 | IR240-R | IR240-R | Calcium Reagent 6 X 250 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
40 | 05055273208368 | CA8309 | CALCIUM (Ca) | RANDOX LABORATORIES LIMITED | ||
41 | 05055273200904 | CA3871 | CA3871 | The calcium test system is a device intended for the quantitative in vitro deter The calcium test system is a device intended for the quantitative in vitro determination of calcium concentration in serum, plasma or urine | Ca | RANDOX LABORATORIES LIMITED |
42 | 05055273200881 | CA2390 | CA2390 | The calcium test system is a device intended for the quantitative in vitro deter The calcium test system is a device intended for the quantitative in vitro determination of calcium concentration in serum, plasma or urine | Calcium (Ca) | RANDOX LABORATORIES LIMITED |
43 | 03610230008607 | 1300047910 | Yumizen C1200 Calcium AS | HORIBA ABX SAS | ||
44 | 03610230005750 | 1220001954 | ABX PENTRA CALCIUM AS CP | HORIBA ABX SAS | ||
45 | 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. |
46 | 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. |
47 | 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. |
48 | 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. |
49 | 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. |
50 | 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. |