Other products from "I-SENS, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00885325000849 164446-201 CareSens N Voice Multi Blood Glucose Monitoring System NBW System, Test, Blood Glucose, Over The Counter 2 CareSens N Voice Multi
2 00885325000764 520050 COOL Blood Glucose Test Strip CGA Glucose Oxidase, Glucose COOL
3 00885325001426 343105 Tempo Blood Glucose Test Strip CGA Glucose Oxidase, Glucose Tempo
4 00885325000443 164442-202 CareSens N Voice Blood Glucose Meter NBW System, Test, Blood Glucose, Over The Counter 2 CareSens N Voice
5 00885325000054 155104 CareSens N Blood Glucose Test Strip CGA Glucose Oxidase, Glucose CareSens N (MedPoint Diagnostics)
6 00885325000047 155300-201 CareSens N Blood Glucose Meter NBW System, Test, Blood Glucose, Over The Counter 2 CareSens N (MedPoint Diagnostics)
7 00857513006209 282104-201 VeraSens Voice Blood Glucose Test Strip CGA Glucose Oxidase, Glucose VeraSens Voice
8 00857513006193 282442 VeraSens Voice Blood Glucose Meter NBW System, Test, Blood Glucose, Over The Counter 2 VeraSens Voice
9 00892896000260 163424-201 Fifty50 Sport Blood Glucose Monitoring System 2.0 CGA,NBW Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter Fifty50 Sport
10 00885325000863 276151 KetoSens B-Ketone Test Strip (individual foiled packs x 50) JIN Nitroprusside, Ketones (Urinary, Non-Quant.) KetoSens
11 00885325000856 276261-201 KetoSens B-Ketone Monitoring System with Lancets JIN Nitroprusside, Ketones (Urinary, Non-Quant.) 1 KetoSens
12 00885325001075 276262 KetoSens B-Ketone Monitoring System with Test Strips (individually foiled packs x 10) JIN Nitroprusside, Ketones (Urinary, Non-Quant.) 1 KetoSens
13 00885325001068 276154 KetoSens B-Ketone Test Strips (individually foiled packs x 50) with 50T lancets JIN Nitroprusside, Ketones (Urinary, Non-Quant.) KetoSens
14 00885325000870 276153-206 KetoSens B-Ketone Test Strip (individual foiled packs x 10) JIN Nitroprusside, Ketones (Urinary, Non-Quant.) KetoSens
15 00885325001198 276150 KetoSens B-Ketone Test Strip (individual foiled packs x 30) JIN Nitroprusside, Ketones (Urinary, Non-Quant.) KetoSens
16 00885325001693 164503 CareSens N Feliz Blood Glucose Monitoring System NBW System, Test, Blood Glucose, Over The Counter 2 CareSens N Feliz
17 00885325001495 276265 KetoSens BT B-Ketone Monitoring System with Test Strips (individually foiled packs x 10) JIN Nitroprusside, Ketones (Urinary, Non-Quant.) 1 KetoSens
18 00885325001280 276156 KetoSens B-Ketone 10T Test Strips with 10T lancets JIN Nitroprusside, Ketones (Urinary, Non-Quant.) KetoSens
19 00885325001273 276155 KetoSens B-Ketone Test Strip (individually foiled packs x 30) with 30T lancets JIN Nitroprusside, Ketones (Urinary, Non-Quant.) KetoSens
20 00885325001266 164221 CareSens II Blood Glucose Monitoring System (Basic meter set) NBW System, Test, Blood Glucose, Over The Counter 2 CareSens II
21 00885325000757 520001 COOL Blood Glucose Meter NBW System, Test, Blood Glucose, Over The Counter 2 COOL
22 00885325000375 521100 COOL Blood Glucose Monitoring System CGA,NBW Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter 2 COOL
23 00885325001686 164508 CareSens N Feliz BT Blood Glucose Monitoring System NBW System, Test, Blood Glucose, Over The Counter 2 CareSens N Feliz BT
24 00885325001419 343104 Tempo Blood Glucose Test Strip CGA Glucose Oxidase, Glucose Tempo
25 00885325001402 343262 Tempo Blood Glucose Monitoring System NBW System, Test, Blood Glucose, Over The Counter 2 Tempo
26 00885325001389 343264 Tempo Blood Glucose Monitoring System NBW System, Test, Blood Glucose, Over The Counter 2 Tempo
27 00885325000610 164104-204 CareSens N Multi Blood Glucose Test Strip CGA Glucose Oxidase, Glucose CareSens N Multi
28 00885325001372 164372 CareSens N Plus BT Blood Glucose Monitoring System NBW System, Test, Blood Glucose, Over The Counter 2 CareSens N Plus BT
29 00885325000818 520010 COOL Blood Glucose Test Strip CGA Glucose Oxidase, Glucose COOL
30 00885325000436 164422 CareSens N POP Blood Glucose Monitoring System NBW,CGA System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose 2 CareSens N POP
31 00885325000115 164301-202 CareSens N Blood Glucose Meter NBW System, Test, Blood Glucose, Over The Counter 2 CareSens N
32 00885325001105 164303-203 CareSens N Blood Glucose Monitoring System (White) NBW,CGA System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose 2 CareSens N
33 00885325001327 164307 CareSens N Blood Glucose Monitoring System NBW,CGA System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose 2 CareSens N
34 00885325001310 164284 CareSens N Blood Glucose Monitoring System NBW,CGA System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose 2 CareSens N
35 00885325001242 164101 CareSens N Blood Glucose Test Strip CGA Glucose Oxidase, Glucose CareSens N
36 00885325000016 164303-201 CareSens N Blood Glucose Monitoring System CGA,NBW Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter 2 CareSens N
37 00885325001211 164303-204 CareSens N Blood Glucose Monitoring System with Test Strips (10T) NBW System, Test, Blood Glucose, Over The Counter 2 CareSens N
38 00892896000093 163604 Fifty50 Blood Glucose Test Strip CGA Glucose Oxidase, Glucose Fifty50
39 00892896000086 163308-302 Fifty50 Blood Glucose Monitoring System 2.0 CGA,NBW Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter 2 Fifty50
40 00892896000017 163140 Fifty50 Blood Glucose Test Strip CGA Glucose Oxidase, Glucose Fifty50
Other products with the same Product Code "CGA"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 04015630946365 07769202001 07769202001 Accutrend Plus Meter Kit ROCHE DIAGNOSTICS GMBH
2 04015630018147 03260895184 03260895184 cobas b 221 GLU Cassette ROCHE DIAGNOSTICS GMBH
3 03760165449225 BW-GL1 BEWELL CONNECT MyGluco VISIOMED GROUP
4 00899722002344 99021 99021 Alere Cholestech LDX® Lipid Profile●GLU Alere Cholestech LDX® ALERE SAN DIEGO, INC.
5 00898302001036 Control 98302-0001-03 Control Solution to apply to Blood Glucose Test Strips to verify the accuracy of Control Solution to apply to Blood Glucose Test Strips to verify the accuracy of readings from a Blood Glucose meter and/or Test Strips. Clever Choice SIMPLE DIAGNOSTICS INC
6 00894472000275 1 BP7564 OPTI CCA E-Glu Cassette OPTI CCA E-Glu Cassette OPTI MEDICAL SYSTEMS, INC.
7 00893038002654 10-991 10-991 Alere Cholestech LDX® Lipid Profile●GLU Alere Cholestech LDX® ALERE SAN DIEGO, INC.
8 00893038002647 10-990 10-990 Alere Cholestech LDX® TC●HDL●GLU Alere Cholestech LDX® ALERE SAN DIEGO, INC.
9 00893038002623 10-988 10-988 Alere Cholestech LDX® TC●GLU Alere Cholestech LDX® ALERE SAN DIEGO, INC.
10 00892896000260 163424-201 Fifty50 Sport Blood Glucose Monitoring System 2.0 Fifty50 Sport I-SENS, INC.
11 00892896000093 163604 Fifty50 Blood Glucose Test Strip Fifty50 I-SENS, INC.
12 00892896000086 163308-302 Fifty50 Blood Glucose Monitoring System 2.0 Fifty50 I-SENS, INC.
13 00892896000017 163140 Fifty50 Blood Glucose Test Strip Fifty50 I-SENS, INC.
14 00891237001645 8818 1645 25ct bottle Blood Glucose Testing Strips for use with Easy Plus II or Easy Talk 25ct bottle Blood Glucose Testing Strips for use with Easy Plus II or Easy Talk monitoring systems Easy Plus II Blood Glucose Testing Strips 25ct HOME AIDE DIAGNOSTICS, INC.
15 00891237001485 8818 1485 25 ct bottle Blood Glucose Testing Strips for use with Easy Talk or Easy Plus II 25 ct bottle Blood Glucose Testing Strips for use with Easy Talk or Easy Plus II monitoring systems Easy Talk Blood Glucose Testing Strips 25ct HOME AIDE DIAGNOSTICS, INC.
16 00891237001423 200020049 1423 25ct bottle Easy Trak blood glucose test strips for use with Easy Trak blood glu 25ct bottle Easy Trak blood glucose test strips for use with Easy Trak blood glucose monitoring system Easy Trak Blood Glucose Test Strips 25ct HOME AIDE DIAGNOSTICS, INC.
17 00891237001195 T5D2-00 1195 50ct box of Easy Step blood glucose test strips for use with Easy Step blood glu 50ct box of Easy Step blood glucose test strips for use with Easy Step blood glucose monitoring system Easy Step Blood Glucose Test Strips 50ct HOME AIDE DIAGNOSTICS, INC.
18 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.
19 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.
20 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.
21 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.
22 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.
23 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.
24 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.
25 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.
26 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.
27 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.
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 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.
30 00887473000160 01GS11 SD GlucoNavii Blood Glucose Test Strip SD BIOSENSOR, INC.
31 00887473000139 01GCS10 SD Glucose Control Solution SD BIOSENSOR, INC.
32 00887473000122 01GS11C SD GlucoNavii Blood Glucose Test Strip SD BIOSENSOR, INC.
33 00887473000108 01GC110 SD GlucoNavii Blood Glucose Monitoring System SD BIOSENSOR, INC.
34 00887473000016 01GM11 SD GlucoNavii Blood Glucose Monitoring System SD BIOSENSOR, INC.
35 00887473000009 01GC111 SD GlucoNavii Blood Glucose Monitoring System SD BIOSENSOR, INC.
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39 00885502000044 IGM-0009 IGM-G3-003 Control™ Starter Kit U.S. DIAGNOSTICS INC.
40 00885502000037 IGM-0008 IGM-G2-101 EasyGluco™G2 Starter Kit U.S. DIAGNOSTICS INC.
41 00885502000006 IGM-0024 G5-003SK INFINITY™ Starter Kit U.S. DIAGNOSTICS INC.
42 00885325001426 343105 Tempo Blood Glucose Test Strip Tempo I-SENS, INC.
43 00885325001419 343104 Tempo Blood Glucose Test Strip Tempo I-SENS, INC.
44 00885325001327 164307 CareSens N Blood Glucose Monitoring System CareSens N I-SENS, INC.
45 00885325001310 164284 CareSens N Blood Glucose Monitoring System CareSens N I-SENS, INC.
46 00885325001242 164101 CareSens N Blood Glucose Test Strip CareSens N I-SENS, INC.
47 00885325001105 164303-203 CareSens N Blood Glucose Monitoring System (White) CareSens N I-SENS, INC.
48 00885325000818 520010 COOL Blood Glucose Test Strip COOL I-SENS, INC.
49 00885325000764 520050 COOL Blood Glucose Test Strip COOL I-SENS, INC.
50 00885325000610 164104-204 CareSens N Multi Blood Glucose Test Strip CareSens N Multi I-SENS, INC.