Other products from "OK BIOTECH CO., LTD."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00193169642409 64240 64240 Blood Glucose Test Strips NBW,CGA System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose TruePoint
2 00193169642362 64236 64236 Blood Glucose Test Strips NBW,CGA System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose TruePoint
3 00193169642331 64233 64233 Blood Glucose Test Strips NBW,CGA System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose TruePoint
4 00193169642324 64232 64232 Blood Glucose Test Strips NBW,CGA System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose TruePoint
5 00193169642300 64230 64230 Blood Glucose Test Strips CGA,NBW Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter TruePoint
Other products with the same Product Codes "NBW, CGA"
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 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.
3 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.
4 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.
5 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.
6 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.
7 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.
8 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.
9 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.
10 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.
11 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.
12 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.
13 00887473000160 01GS11 SD GlucoNavii Blood Glucose Test Strip SD BIOSENSOR, INC.
14 00887473000160 01GS11 SD GlucoNavii Blood Glucose Test Strip SD BIOSENSOR, INC.
15 00887473000139 01GCS10 SD Glucose Control Solution SD BIOSENSOR, INC.
16 00887473000139 01GCS10 SD Glucose Control Solution SD BIOSENSOR, INC.
17 00887473000122 01GS11C SD GlucoNavii Blood Glucose Test Strip SD BIOSENSOR, INC.
18 00887473000122 01GS11C SD GlucoNavii Blood Glucose Test Strip SD BIOSENSOR, INC.
19 00887473000108 01GC110 SD GlucoNavii Blood Glucose Monitoring System SD BIOSENSOR, INC.
20 00887473000108 01GC110 SD GlucoNavii Blood Glucose Monitoring System SD BIOSENSOR, INC.
21 00887473000016 01GM11 SD GlucoNavii Blood Glucose Monitoring System SD BIOSENSOR, INC.
22 00887473000016 01GM11 SD GlucoNavii Blood Glucose Monitoring System SD BIOSENSOR, INC.
23 00887473000009 01GC111 SD GlucoNavii Blood Glucose Monitoring System SD BIOSENSOR, INC.
24 00887473000009 01GC111 SD GlucoNavii Blood Glucose Monitoring System SD BIOSENSOR, INC.
25 00885502001041 IGM-0009 IGM-G3-103 Control™ Meter Kit U.S. DIAGNOSTICS INC.
26 00885502001041 IGM-0009 IGM-G3-103 Control™ Meter Kit U.S. DIAGNOSTICS INC.
27 00885502001034 IGM-0008 IGM-G2-103 EasyGluco™G2 Meter Kit U.S. DIAGNOSTICS INC.
28 00885502001034 IGM-0008 IGM-G2-103 EasyGluco™G2 Meter Kit U.S. DIAGNOSTICS INC.
29 00885502001003 IGM-0024 G5-103MK INFINITY™ Meter Kit U.S. DIAGNOSTICS INC.
30 00885502001003 IGM-0024 G5-103MK INFINITY™ Meter Kit U.S. DIAGNOSTICS INC.
31 00885502000044 IGM-0009 IGM-G3-003 Control™ Starter Kit U.S. DIAGNOSTICS INC.
32 00885502000044 IGM-0009 IGM-G3-003 Control™ Starter Kit U.S. DIAGNOSTICS INC.
33 00885502000037 IGM-0008 IGM-G2-101 EasyGluco™G2 Starter Kit U.S. DIAGNOSTICS INC.
34 00885502000037 IGM-0008 IGM-G2-101 EasyGluco™G2 Starter Kit U.S. DIAGNOSTICS INC.
35 00885502000006 IGM-0024 G5-003SK INFINITY™ Starter Kit U.S. DIAGNOSTICS INC.
36 00885502000006 IGM-0024 G5-003SK INFINITY™ Starter Kit U.S. DIAGNOSTICS INC.
37 00885325001693 164503 CareSens N Feliz Blood Glucose Monitoring System CareSens N Feliz I-SENS, INC.
38 00885325001686 164508 CareSens N Feliz BT Blood Glucose Monitoring System CareSens N Feliz BT I-SENS, INC.
39 00885325001426 343105 Tempo Blood Glucose Test Strip Tempo I-SENS, INC.
40 00885325001419 343104 Tempo Blood Glucose Test Strip Tempo I-SENS, INC.
41 00885325001402 343262 Tempo Blood Glucose Monitoring System Tempo I-SENS, INC.
42 00885325001389 343264 Tempo Blood Glucose Monitoring System Tempo I-SENS, INC.
43 00885325001372 164372 CareSens N Plus BT Blood Glucose Monitoring System CareSens N Plus BT I-SENS, INC.
44 00885325001327 164307 CareSens N Blood Glucose Monitoring System CareSens N I-SENS, INC.
45 00885325001327 164307 CareSens N Blood Glucose Monitoring System CareSens N I-SENS, INC.
46 00885325001310 164284 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 00885325001266 164221 CareSens II Blood Glucose Monitoring System (Basic meter set) CareSens II I-SENS, INC.
49 00885325001242 164101 CareSens N Blood Glucose Test Strip CareSens N I-SENS, INC.
50 00885325001211 164303-204 CareSens N Blood Glucose Monitoring System with Test Strips (10T) CareSens N I-SENS, INC.