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 "CEK"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 15099590625610 442740 442740 Total Protein Reagent (TP 2 x 300) Synchron BECKMAN COULTER, INC.
2 15099590575151 445860 445860 Microprotein Reagent (M-TP 2 x 50) Synchron BECKMAN COULTER, INC.
3 15099590233327 465986 465986 Total Protein Reagent Synchron BECKMAN COULTER, INC.
4 15099590060091 OSR6632 Total Protein AU BECKMAN COULTER, INC.
5 15099590020347 OSR6270 Urinary/CSF Protein AU BECKMAN COULTER, INC.
6 15099590020156 OSR6232 Total Protein AU BECKMAN COULTER, INC.
7 15099590010676 OSR6170 Urinary/CSF Protein AU BECKMAN COULTER, INC.
8 15099590010294 OSR6132 Total Protein AU BECKMAN COULTER, INC.
9 10758750004850 8392292 8392292 VITROS Chemistry Products TP Slides VITROS ORTHO-CLINICAL DIAGNOSTICS, INC.
10 10758750004539 8208431 8208431 VITROS Chemistry Products PROT Slides VITROS ORTHO-CLINICAL DIAGNOSTICS, INC.
11 M0515210120 5210-12 5210-12 QuanTtest red Reagent is a ready-to-use liquid in 250 mL bottles containing Pyro QuanTtest red Reagent is a ready-to-use liquid in 250 mL bottles containing Pyrogallol Red. The reagent is intended for use in assays for quantitative determination of protein in cerebrospinal fluid and urine, for both manual and automated systems. QuanTtest Red Pyrogallol Red Reagent QUANTIMETRIX CORPORATION
12 M0513410021 3410-02 3410-02 QuanTtest Human Protein Standards are intended to be used with the QuanTtest Red QuanTtest Human Protein Standards are intended to be used with the QuanTtest Red (Pyrogallol Red method) Total Protein Assay System. The standards are used to establish curves and to calibrate manual and automated methods for cerebrospinal fluid and urine total protein assays. Four protein standard concentrations are available: 25, 50, 100, and 200 mg/dl. QuanTtest Human Protein Standards Set QUANTIMETRIX CORPORATION
13 M0512210021 2210-02 2210-02 The quanTtest red Total Protein Assay System is intended for the quantitative de The quanTtest red Total Protein Assay System is intended for the quantitative determination of protein in cerebrospinal fluid and urine for both manual and automated systems. The quanTtest red Total Protein Assay System provides a simple method of protein quantitation using microliter samples of urine or cerebrospinal fluid. Total Protein is measured by the dye binding method using a complex of pyrogallol red and molybdenum acid (Mo+6). At low pH the dye is red and changes to blue when complexed with protein.The kit consists of reagent, controls for both CSF and urine chemistry, and four reagent standards: Level 2 (25 mg/dL), Level 3 (50 mg/dL), Level 4 (100 mg/dL), and Level 5 (200 mg/dL). QuanTtest Red Reagent Total Protein Assay System QUANTIMETRIX CORPORATION
14 07613336121528 08058652190 08058652190 Total Protein Gen.2 ROCHE DIAGNOSTICS GMBH
15 06970291985208 None Total Protein Kit (Biuret Method) (2-Part Reagents) MEDICALSYSTEM BIOTECHNOLOGY CO., LTD.
16 06970291985192 None Total Protein Kit (Biuret Method) MEDICALSYSTEM BIOTECHNOLOGY CO., LTD.
17 05060500091941 VI530-1200 VI530-1200 Total Protein Reagent 6 X 67 mL + 3 X 67 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
18 05060500091361 VI133-L VI133-L Total Protein Biuret Reagent 6 X 1000 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
19 05060500091354 VI131-L VI131-L Total Protein Buffer Reagent 6 X 1000 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
20 05060500091347 VI530-911 VI530-911 Total Protein Reagent 4 X 50 mL + 2 X 40 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
21 05060500091330 VI530-WK VI530-WK Total Protein Reagent 3 X 25 mL + 3 X 12.5 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
22 05060500091323 VI530-X VI530-X Total Protein Reagent 1 X 250 mL + 1 X 125 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
23 05060500091316 VI530-R VI530-R Total Protein Reagent 4 X 250 mL + 2 X 250 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
24 05060500091309 VI135-L VI135-L Total Protein Single Reagent 6 X 1000 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
25 05060500091293 VI135-X VI135-X Total Protein Single Reagent 2 X 250 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
26 05060500091286 VI135-R VI135-R Total Protein Single Reagent 6 X 250 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
27 05055273209518 TP8336 TOTAL PROTEIN 2 (TP 2) RANDOX LABORATORIES LIMITED
28 05055273209501 TP8066 TOTAL PROTEIN 2 (TP 2) RANDOX LABORATORIES LIMITED
29 05055273206562 TP4001 For the quantitative in vitro determination of Total Protein in serum. TOTAL PROTEIN 2 (TP 2) RANDOX LABORATORIES LIMITED
30 05055273206555 TP3869 For the quantitative in vitro determination of Total Protein in serum and plasma. TOTAL PROTEIN (TP) RANDOX LABORATORIES LIMITED
31 05055273206531 TP245 For the quantitative in vitro determination of Total Protein in serum and plasma. TOTAL PROTEIN (TP) RANDOX LABORATORIES LIMITED
32 04015630925100 5171385190 5171385190 Total Protein Gen2 ROCHE DIAGNOSTICS GMBH
33 04015630922833 4657586190 4657586190 Total Protein Gen2 monocromatic ROCHE DIAGNOSTICS GMBH
34 04015630918928 3183734190 3183734190 Total Protein Gen2 ROCHE DIAGNOSTICS GMBH
35 04015630912445 12000920216 12000920216 Total Protein ROCHE DIAGNOSTICS GMBH
36 04015630912438 12000903216 12000903216 Total Protein ROCHE DIAGNOSTICS GMBH
37 04015630911875 11929917216 11929917216 Total Protein ROCHE DIAGNOSTICS GMBH
38 03610230007174 1300023865 Yumizen C1200 Total Protein HORIBA ABX SAS
39 03610230005729 1220001932 ABX PENTRA TOTAL PROTEIN 100 CP HORIBA ABX SAS
40 03610230005224 1220001669 ABX PENTRA TOTAL PROTEIN CP HORIBA ABX SAS
41 00896863002356 3410-02 3410-02 QuanTtest Human Protein Standards are intended to be used with the QuanTtest Red QuanTtest Human Protein Standards are intended to be used with the QuanTtest Red (Pyrogallol Red method) Total Protein Assay System. The standards are used to establish curves and to calibrate manual and automated methods for cerebrospinal fluid and urine total protein assays. Four protein standard concentrations are available: 25, 50, 100, and 200 mg/dl. QuanTtest Human Protein Standards Set QUANTIMETRIX CORPORATION
42 00896863002349 5210-12 5210-12 QuanTtest red Reagent is a ready-to-use liquid in 250 mL bottles containing Pyro QuanTtest red Reagent is a ready-to-use liquid in 250 mL bottles containing Pyrogallol Red. The reagent is intended for use in assays for quantitative determination of protein in cerebrospinal fluid and urine, for both manual and automated systems. QuanTtest Red Pyrogallol Red Reagent QUANTIMETRIX CORPORATION
43 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.
44 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.
45 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.
46 EABA40000261 400-0026 400-0026 The Piccolo® Hepatic Function Panel, used with the Piccolo Xpress® chemistry ana The Piccolo® Hepatic Function Panel, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitroquantitative determinations of alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, directbilirubin, total bilirubin, and total protein in heparinized whole blood, heparinized plasma, or serum in a clinical laboratorysetting or point-of-care location. Piccolo Hepatic Function Panel ABAXIS, INC.
47 EABA40000031 400-0003 400-0003 The Piccolo® Liver Panel Plus, used with the Piccolo® blood chemistry analyzer o The Piccolo® Liver Panel Plus, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, utilizes dry and liquid reagents to provide in vitro quantitative determinations of alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, gamma glutamyltransferase, total bilirubin, and total protein 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 Liver Panel Plus ABAXIS, INC.
48 00857969006235 SA1022 SA1022 Total Protein Reagent ACE ALFA WASSERMANN, INC.
49 00852169008249 TPR1310 TPR1310 In Vitro Diagnostics testing kit R1:4X60mL ClearChem Diagnostics Inc. Protein, Total CLEARCHEM DIAGNOSTICS INC.
50 00851445007303 GEN-TP3 GEN-TP3 10/17/2022 GENCHEM™ Total Protein Reagent GENCHEM INC