Other products from "STANBIO LABORATORY, L.P."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00657498300039 G3000-CONTCUV G3000-CONTCUV The HemoPoint® H2 system is intended for the quantitative determination of hemog The HemoPoint® H2 system is intended for the quantitative determination of hemoglobin (Hgb) in whole blood of adults, infants, and children in a professional point-of-care setting. It consists of a dedicated photometer and individual, single-use microcuvettes filled with reagents. GKR System, Hemoglobin, Automated 2 HemoPoint H2
2 00657498002261 7014-204 7014-204 Blood Glucose Control Solution is intended for use with EKF Diagnostic’s Blood G Blood Glucose Control Solution is intended for use with EKF Diagnostic’s Blood Glucose Test Strip. It is used to check that the meter and test strips are working together properly. It is important to do control solution tests routinely to ensure getting accurate results. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Blood Glucose Control Solution
3 00657498001776 20270479 20270479 For use to wash the ISE module and sample probe. Sirrus® ISE Wash Solution
4 00657498001530 S0370-600 S0370-600 For the Quantitative Colorimetric Determination of Iron in Serum. JIY Photometric Method, Iron (Non-Heme) 1 Sirrus® Total Iron LiquiColor®
5 00657498001509 S0250-750 S0250-750 For the Quantitative Colorimetric Determination of Total Protein in Serum. CEK Biuret (Colorimetric), Total Protein 2 Sirrus® Total Protein LiquiColor®
6 00657498001479 S0190-750 S0190-750 For the Quantitative Determination of Bicarbonate (CO2) in Serum and Plasma. KHS Enzymatic, Carbon-Dioxide 2 Sirrus® Bicarbonate (CO2) LiquiColor®
7 00657498001356 1430-050 1430-050 A Qualitative Immunoassay for the Detection of Human Chorionic Gonadotropin (hCG A Qualitative Immunoassay for the Detection of Human Chorionic Gonadotropin (hCG) in Urine. JHI Visual, Pregnancy Hcg, Prescription Use TRUE® 20 hCG
8 00657498001141 1012-030 1012-030 Quantitative-Enzymatic-Colorimetric Determination of Total and HDL Cholesterol i Quantitative-Enzymatic-Colorimetric Determination of Total and HDL Cholesterol in Serum or Plasma. CHH Enzymatic Esterase--Oxidase, Cholesterol 1 Cholesterol Standard (200 mg/dL)
9 00657498001127 0550-605 0550-605 For use as a multi-calibrator serum to calibrate different chemistry reagent use For use as a multi-calibrator serum to calibrate different chemistry reagent used in manual and automated clinical chemistry methods. JIX Calibrator, Multi-Analyte Mixture 2 Ser-T-Cal Multicalibrator
10 00657498001042 2200-225 2200-225 For the Quantitative Enzymatic-Colorimetric Determination of Triglycerides in Se For the Quantitative Enzymatic-Colorimetric Determination of Triglycerides in Serum or Plasma. CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides 1 Triglyceride LiquiColor® (Mono)
11 00657498001035 2200-430 2200-430 For the Quantitative Enzymatic-Colorimetric Determination of Triglycerides in Se For the Quantitative Enzymatic-Colorimetric Determination of Triglycerides in Serum or Plasma. CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides 1 Triglyceride LiquiColor® (Mono)
12 00657498000861 2370-401 2370-401 Stanbio Glycated Serum Protein (GSP) Control Kit is intended to be used for qual Stanbio Glycated Serum Protein (GSP) Control Kit is intended to be used for quality control procedures in examining the accuracy and precision of Stanbio Glycated Serum Protein LiquiColor® Assay (REF 2350-062). JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Glycated Serum Protein Bi-Level Control Set
13 00657498000847 2350-062 2350-062 Stanbio Glycated Serum Protein (GSP) Assay in conjunction with Stanbio Glycated Stanbio Glycated Serum Protein (GSP) Assay in conjunction with Stanbio Glycated Serum Protein calibrator, are intended for the quantitative determination of glycated serum proteins (GSP; glycated albumin; fructosamine) in serum. The measurement of glycated serum proteins is useful for monitoring diabetic patients. LCP Assay, Glycosylated Hemoglobin 2 Glycated Serum Protein (GSP) LiquiColor®
14 00657498000533 2460-605 2460-605 For Use as Controls in Quantitative Procedures for Acetaminophen, Salicylate, an For Use as Controls in Quantitative Procedures for Acetaminophen, Salicylate, and ß-Hydroxybutyrate. DIF Drug Mixture Control Materials 1 TDM/B-Hydroxybutyrate Tri-Level Controls
15 00657498000526 B2440-180 B2440-180 For the Quantitative Determination of ß-Hydroxybutyrate in Serum or Plasma. JIN Nitroprusside, Ketones (Urinary, Non-Quant.) 1 Synchron® CX/LX/DX B-Hydroxybutyrate LiquiColor®
16 00657498000519 2440-058 2440-058 For the Quantitative Determination of ß-Hydroxybutyrate in Human Serum or Plasma. JIN Nitroprusside, Ketones (Urinary, Non-Quant.) 1 B-Hydroxybutyrate LiquiColor®
17 00657498000489 2970-430 2970-430 For the Quantitative Determination of Amylase in Serum and Urine. JFJ Catalytic Methods, Amylase 2 a-Amylase LiquiColor®
18 00657498000120 202000 202000 STAT-Site® Diluent is intended to be used with the STAT-Site® M β-HB Test Strips STAT-Site® Diluent is intended to be used with the STAT-Site® M β-HB Test Strips or KetoSite® Test Cards to dilute specimens containing high levels of β-hydroxybutyrate into the test range of 0 – 2 mM. Additionally, the diluent helps to eliminate possible matrix effects caused by interfering substances such as acetoacetate. JIN Nitroprusside, Ketones (Urinary, Non-Quant.) 1 STAT-Site Diluent
19 00657498000014 6300-020 6300-020 For the Qualitative Detection of IgG Antibodies to Helicobacter pylori (H. pylor For the Qualitative Detection of IgG Antibodies to Helicobacter pylori (H. pylori) in Whole blood, Serum or Plasma. LYR Helicobacter Pylori RELY® H.Pylori
20 00657498301654 3016-050 3016-050 For the quantitative determination of hemoglobin in capillary, venous or arteria For the quantitative determination of hemoglobin in capillary, venous or arterial whole blood. GKR System, Hemoglobin, Automated HemoPoint® H2 n•x•t Microcuvettes
21 00657498001837 S0130-600 S0130-600 For the Quantitative Determination of Magnesium in Serum, Plasma or Urine. JGJ Photometric Method, Magnesium 1 Sirrus® Magnesium LiquiColor®
22 00657498001561 S0590-540 S0590-540 For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol in Human Serum. LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl 1 Sirrus® Direct HDL Cholesterol LiquiColor®
23 00657498001523 S0360-200 S0360-200 For the Quantitative Determination of Glycohemoglobin (HbA1c) in human blood. LCP Assay, Glycosylated Hemoglobin 2 Sirrus® Direct Gylcohemoglobin (HbA1c)
24 00657498001486 S0230-600 S0230-600 For the Quantitative Colorimetric Determination of Total Bilirubin in Serum and Plasma. JFM Enzymatic Method, Bilirubin 2 Sirrus® Total Bilirubin LiquiColor®
25 00657498001318 1230-025 1230-025 For the qualitative determination of human chorionic gonadotropin (hCG) in serum For the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. JHI Visual, Pregnancy Hcg, Prescription Use QuPID® Plus hCG Pregnancy Test
26 00657498001301 1170-500 1170-500 Carbon flocculation slide test for the qualitative and quantitative determinatio Carbon flocculation slide test for the qualitative and quantitative determination of reagin antibodies in serum or plasma. GMQ Antigens, Nontreponemal, All 2 RPR Quicktest
27 00657498001295 1170-100 1170-100 Carbon flocculation slide test for the qualitative and quantitative determinatio Carbon flocculation slide test for the qualitative and quantitative determination of reagin antibodies in serum or plasma. GMQ Antigens, Nontreponemal, All 2 RPR Quicktest
28 00657498001219 G428-86 G428-86 Use as a control serum to monitor the accuracy and precision of manual and autom Use as a control serum to monitor the accuracy and precision of manual and automated methods used in clinical chemistry. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Ser-T-Fy 2, Level 2 Control
29 00657498001066 2100-225 2100-225 For the Quantitative Enzymatic- Colorimetric Determination of Triglycerides in S For the Quantitative Enzymatic- Colorimetric Determination of Triglycerides in Serum or Plasma. CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides 1 Triglyceride LiquiColor®
30 00657498001059 2100-430 2100-430 For the Quantitative Enzymatic- Colorimetric Determination of Triglycerides in S For the Quantitative Enzymatic- Colorimetric Determination of Triglycerides in Serum or Plasma. CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides 1 Triglyceride LiquiColor®
31 00657498000809 1060-500 1060-500 For the Quantitative Determination of Glucose in Serum or Plasma. CFR Hexokinase, Glucose 2 Glucose Liqui-UV®
32 00657498000632 0210-250 0210-250 Quantitative Colorimetric Determination of Chloride in Serum, Plasma, Urine and CSF. CHJ Mercuric Thiocyanate, Colorimetry, Chloride 2 Chloride LiquiColor®
33 00657498000236 3025-050 3025-050 For the quantitative determination of hemoglobin in capillary, venous or arteria For the quantitative determination of hemoglobin in capillary, venous or arterial whole blood. GKR System, Hemoglobin, Automated n•x•t Microcuvette
34 00657498000168 503000 503000 A bi-level reference control intended for use on STAT-Site® and HemoSite® hemogl A bi-level reference control intended for use on STAT-Site® and HemoSite® hemoglobin testing systems, including the STAT-Site® MHgb Test System. JPK Mixture, Hematology Quality Control 2 STAT-Site Hgb Controls
35 00657498000113 303500 303500 The STAT-Site® Linearity Check is intended to be used to perform a linearity eva The STAT-Site® Linearity Check is intended to be used to perform a linearity evaluation of the STAT-Site® Mβ-HB Test Strips /KetoSite® Test Cards by making a series of dilutions using STAT-Site® Diluent (Catalog No. 202000). Both the STAT-Site® Mβ-HB Test Strips and KetoSite® Test Cards are used in the measurement of β-hydroxybutyrate with the STAT-Site® Mβ-HB and STAT-Site® Meter. JIN Nitroprusside, Ketones (Urinary, Non-Quant.) 1 STAT-Site Linearity Check
36 00657498002377 3063-006 3063-006 A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 HGB Controls - High
37 00657498002360 3063-003 3063-003 A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 HGB Controls - High
38 00657498002216 7010-100 7010-100 The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together wi The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary, venous and neonatal capillary heelstick whole blood samples. It should not be used for the diagnosis of or screening for diabetes. LFR Glucose Dehydrogenase, Glucose STAT-Site WB Blood Glucose Test Strips
39 00657498002209 7010-050 7010-050 The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together wi The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary, venous and neonatal capillary heelstick whole blood samples. It should not be used for the diagnosis of or screening for diabetes. LFR Glucose Dehydrogenase, Glucose STAT-Site WB Blood Glucose Test Strips
40 00657498002193 7010-025 7010-025 The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together wi The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary, venous and neonatal capillary heelstick whole blood samples. It should not be used for the diagnosis of or screening for diabetes. LFR Glucose Dehydrogenase, Glucose STAT-Site WB Blood Glucose Test Strips
41 00657498002131 4000-100 4000-100 Nitro-tab Ketone Tablets are for the semi-quantitative determination of ketones Nitro-tab Ketone Tablets are for the semi-quantitative determination of ketones (acetoacetic acid and acetone) in urine, serum, plasma, and whole blood. JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Nitro-tab Ketone Tablets
42 00657498002025 3060-101N 3060-101N A single level reference control intended for use on HemoPoint® H2 Hemoglobin te A single level reference control intended for use on HemoPoint® H2 Hemoglobin testing system. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Hgb Control, Normal
43 00657498001905 20270476 20270476 Ion-Selective Electrode for the measurement of potassium in serum. CEM Electrode, Ion Specific, Potassium 2 ISE Potassium Electrode
44 00657498001790 A469-98 A469-98 To provide calibration points for the Sodium, Potassium, and Chloride electrodes To provide calibration points for the Sodium, Potassium, and Chloride electrodes on the ISE module of Roche Cobas Chemistry Systems. JIX Calibrator, Multi-Analyte Mixture 2 Standard 2
45 00657498001752 20270477 20270477 The ISE Calibrator 1 for the Sirrus® is an in vitro diagnostic calibrator system The ISE Calibrator 1 for the Sirrus® is an in vitro diagnostic calibrator system intended for use on the Sirrus® Chemistry Analyzer to calibrate the ISE module option for chloride, potassium and sodium. JIX Calibrator, Multi-Analyte Mixture 2 Sirrus® ISE Calibrator 1
46 00657498001745 2211-600 2211-600 For use as a probe cleaner on the Sirrus® Chemistry Analyzer. Sirrus® Probe Cleaner
47 00657498001639 S2200-750 S2200-750 For the Quantitative Colorimetric Determination of Triglycerides in Serum and Plasma. CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides 1 Sirrus® Triglyceride LiquiColor®
48 00657498001615 S1060-600 S1060-600 For the Quantitative Determination of Glucose in Serum, Plasma, CSF or Urine. CFR Hexokinase, Glucose 2 Sirrus® Glucose Liqui-UV®
49 00657498001257 1130-100 1130-100 Latex agglutination slide test for the Qualitative and Semi-quantitative determi Latex agglutination slide test for the Qualitative and Semi-quantitative determination of C-Reactive Protein in non-diluted serum. DCN System, Test, C-Reactive Protein 2 RaPET® CRP
50 00657498001240 1130-050 1130-050 Latex agglutination slide test for the Qualitative and Semi-quantitative determi Latex agglutination slide test for the Qualitative and Semi-quantitative determination of C-Reactive Protein in non-diluted serum. DCN System, Test, C-Reactive Protein 2 RaPET® CRP
Other products with the same Product Code "CGX"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 05060500091873 VI560-1200 VI560-1200 Creatinine Reagent 4 X 67 mL + 4 X 67 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
2 05060500090784 VI562-L VI562-L Creatinine Picrate Reagent 6 X 500 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
3 05060500090777 VI561-L VI561-L Creatinine Decolorizing Reagent 6 X 500 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
4 05060500090760 VI560-911 VI560-911 Creatinine Reagent 4 X 50 mL + 4 X 50 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
5 05060500090753 VI560-WK VI560-WK Creatinine Reagent 3 X 25 mL + 3 X 25 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
6 05060500090746 VI5600-X VI5600-X Creatinine Reagent 1 X 250 mL + 1 X 250 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
7 05060500090739 VI560-R VI560-R Creatinine Reagent 3 X 250 mL + 3 X 250 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
8 05055273208634 CR8316 CR8316 The is intended for the quantitative in vitro diagnostic determination of Creati The is intended for the quantitative in vitro diagnostic determination of Creatinine in serum, plasma or urine CREA RANDOX LABORATORIES LIMITED
9 05055273201932 CR7948 CR7948 The is intended for the quantitative in vitro diagnostic determination of Creati The is intended for the quantitative in vitro diagnostic determination of Creatinine in serum, plasma or urine CREA RANDOX LABORATORIES LIMITED
10 05055273201918 CR524 CR524 The device intended for the quantitative in vitro determination of Creatinine in The device intended for the quantitative in vitro determination of Creatinine in serum, plasma or urine CREA RANDOX LABORATORIES LIMITED
11 05055273201901 CR510 CR510 CREATININE (CREA) RANDOX LABORATORIES LIMITED
12 05055273201895 CR3814 CR3814 The is intended for the quantitative in vitro diagnostic determination of Creati The is intended for the quantitative in vitro diagnostic determination of Creatinine in serum, plasma or urine CREA RANDOX LABORATORIES LIMITED
13 05055273201888 CR2804 CR2804 The CREA method used on the Dimension clinical chemistry system is an in vitro d The CREA method used on the Dimension clinical chemistry system is an in vitro diagnostic device intended for the quantitative determination of Creatinine in serum, plasma or urine CREA RANDOX LABORATORIES LIMITED
14 04015630930777 6407137190 6407137190 Creatinine Jaff Gen2 ROCHE DIAGNOSTICS GMBH
15 04015630926824 5401755190 5401755190 Creatinine Jaff Gen2 compensated) ROCHE DIAGNOSTICS GMBH
16 04015630922284 4810716190 4810716190 Creatinine Jaff Gen2 ROCHE DIAGNOSTICS GMBH
17 04015630918355 11929941216 11929941216 Creatinine Jaff method ROCHE DIAGNOSTICS GMBH
18 04015630910762 11875663216 11875663216 Creatinine Jaff method ROCHE DIAGNOSTICS GMBH
19 04015630910427 11875418216 11875418216 Creatinine Jaff method ROCHE DIAGNOSTICS GMBH
20 03610230006955 1300023842 Yumizen C1200 Creatinine Jaffé HORIBA ABX SAS
21 03610230005736 1220001933 ABX PENTRA CREATININE 120 CP HORIBA ABX SAS
22 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.
23 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.
24 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.
25 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.
26 EABA40000331 400-0033 400-0033 The Piccolo® Kidney Check , used with the Piccolo Xpress chemistry analyzer, is The Piccolo® Kidney Check , used with the Piccolo Xpress chemistry analyzer, is intended to be used for the in vitro quantitative determination of creatinine 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 Kidney Check ABAXIS, INC.
27 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.
28 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.
29 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.
30 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.
31 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.
32 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.
33 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.
34 00857969006112 SA1012 SA1012 Creatinine Reagent ACE ALFA WASSERMANN, INC.
35 00857969006068 RX1012 RX1012 Creatinine Reagent ACE ALFA WASSERMANN, INC.
36 00852169008126 CRE1120 CRE1120 In Vitro Diagnostics testing kit R1:3X50mL, R2:3X10mL ClearChem Diagnostics Inc. Creatinine (Jaffe) CLEARCHEM DIAGNOSTICS INC.
37 00851445007181 GEN-CREA R2(Acid) GEN-CREA R2(Acid) 10/17/2022 GENCHEM™ Creatinine Test Reagent GENCHEM INC
38 00851445007174 GEN-CREA R1(Base) GEN-CREA R1(Base) 10/17/2022 GENCHEM™ Creatinine Test Reagent GENCHEM INC
39 00845275003031 TR35121 Thermo Scientific Infinity™ FISHER DIAGNOSTICS
40 00817302024326 CC448 CC448 CREATININE CHECK CAROLINA LIQUID CHEMISTRIES CORP.® CREATININE CHECK REAGENT KIT CC448 CAROLINA LIQUID CHEMISTRIES CORPORATION
41 00817302020564 88809 88809 CREA3 (Creatinine) - Modular & CX3 Reagent 3 x 2000 mL CAROLINA LIQUID CHEMISTRIES CORP.® CREATININE REAGENT KIT 88809 CAROLINA LIQUID CHEMISTRIES CORPORATION
42 00817302020557 CC243 CC243 CREA (Creatinine) 2 x 300 tests CAROLINA LIQUID CHEMISTRIES CORP.® CREA CREATININE REAGENT CC243 CAROLINA LIQUID CHEMISTRIES CORPORATION
43 00817302020540 AU-243 AU-243 CREA (Creatinine) 3 x 300 tests CAROLINA LIQUID CHEMISTRIES CORP.® CREA RGT. KIT AU-243 CAROLINA LIQUID CHEMISTRIES CORPORATION
44 00817274022337 OCRE2-50 OCRE2-50 CREATININE (5 x 50mL) JAS Diagnostics DREW SCIENTIFIC, INC.
45 00817274021460 CRES-3U CREATININE STANDARD (1x 3mL) Unlabeled Vial JAS Diagnostics DREW SCIENTIFIC, INC.
46 00817274021453 CRES-3 CREATININE STANDARD (1x 3mL) JAS Diagnostics DREW SCIENTIFIC, INC.
47 00817274021446 CRE2-BUL CREATININE SINGLE VIAL BULK (in 20L Pkg) JAS Diagnostics DREW SCIENTIFIC, INC.
48 00817274021439 DG-CRE2-125 CREATININE LIQUID (2x 125mL + 1x 3mL Standard) JAS Diagnostics DREW SCIENTIFIC, INC.
49 00817274021422 DG-CRE2-1L CREATININE LIQUID (1 x 1 Liter + 1 x 5mL Standard) JAS Diagnostics DREW SCIENTIFIC, INC.
50 00817274021415 CRE2-1L CREATININE LIQUID (1x 1L) JAS Diagnostics DREW SCIENTIFIC, INC.