Other products from "RANDOX LABORATORIES LIMITED"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 05055273207071 CPL4017 DDB Ceruloplasmin, Antigen, Antiserum, Control 2 CERULOPLASMIN (CPL)
2 05055273203400 GR2368 KQF Assay, Glutathione Reductase 2 GLUTATHIONE REDUCTASE (GLUT RED)
3 05055273209587 UP8113 JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) 1 TOTAL PROTEIN (UP)
4 05055273207118 LUN5048 OHQ Multi-Analyte Controls Unassayed 1 LIQUID CHEMISTRY PREMIUM - LEVEL 2 (LIQ CHEM PREMIUM 2)
5 05055273207163 LUL5093 OHQ Multi-Analyte Controls Unassayed 1 LIQUID CHEMISTRY PREMIUM PLUS - LEVEL 1 (LIQ CHEM PREMIUM PLUS 1)
6 05055273204322 LO3999 GTQ Antistreptolysin - Titer/Streptolysin O Reagent 1 ANTI-STREPTOLYSIN-O 2 (ASO 2)
7 05055273203516 GY1369 JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 GLYCEROL CONTROL (GLY CONTROL)
8 05055273203066 FA115 JLG Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids 1 Non-Esterified Fatty Acids (NEFA)
9 05055273200164 AL1205 AL1205 CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt 1 ALANINE AMINOTRANSFERASE (ALT)
10 05055273217766 AMH10516 AMH10516 The AMH Control Level 4 (AMH10516) is intended for use with in vitro diagnostic The AMH Control Level 4 (AMH10516) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti-Müllerian Hormone in human serum and plasma. The AMH Control Level 4 (AMH10516) is assayed with target values and is suitable for use on automated analysers.The AMH Control Level 4 (AMH10516) is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 AMH CONTROL LEVEL 4 (AMH CONTROL 4)
11 05055273217667 CQ10430 CQ10430 This product is intended for in vitro use, in the quality control of Cardiac Mar This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 CARDIAC CONTROL - LEVEL 2 (CRD CONTROL 2)
12 05055273215205 LE10175 JJY Multi-Analyte Controls, All Kinds (Assayed) 1 LIQUID FROZEN LIPID CONTROL - LEVEL 2 (LIQ LPD CONTROL 2)
13 05055273215175 BR10172 JJY Multi-Analyte Controls, All Kinds (Assayed) 1 LIQUID BILIRUBIN CONTROL - LEVEL 1 (LIQ BIL CONTROL 1)
14 05055273214338 RX4045 RX4045 This is required for measuring reference electrode potential of an ion selective This is required for measuring reference electrode potential of an ion selective electrode module. JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1 REF SOLN
15 05055273214307 RP8398 RP8398 The Reagent Precision Test is used on the RX series clinical chemistry systems f The Reagent Precision Test is used on the RX series clinical chemistry systems for checking proper functioning of the reagent fluid metering and photometric measuring system. JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1 RABS
16 05055273213966 CH2656 Enzymatic Clearance assay for the in vitro quantitative determination of LDL-cho Enzymatic Clearance assay for the in vitro quantitative determination of LDL-cholesterol in human serum and plasma. MRR System, Test, Low Density, Lipoprotein 1 DIRECT LDL-CHOLESTEROL (LDL)
17 05055273210378 RX8106 RX8106 Antibacterial Detergent is used for cleaning the instrument probe and reaction cuvettes. JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1 ANTI-BACTERIAL DETERGENT (Detergent)
18 05055273209389 SA8396 SA8396 This product should be used in conjunction with RX daytona plus reagents to dilu This product should be used in conjunction with RX daytona plus reagents to dilute samples prior to assay. JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1 NS
19 05055273209211 LP8007 MSJ Apolipoproteins 1 APOLIPOPROTEIN A-I (APO A-I)
20 05055273209204 LP5047 JIT Calibrator, Secondary 2 APOLIPOPROTEIN CALIBRATOR 2 (APO CAL 2)
21 05055273209181 LO8305 GTQ Antistreptolysin - Titer/Streptolysin O Reagent 1 ANTI-STREPTOLYSIN-O 2 (ASO 2)
22 05055273209174 LO8015 GTQ Antistreptolysin - Titer/Streptolysin O Reagent 1 ANTI-STREPTOLYSIN-O 2 (ASO 2)
23 05055273209143 LM4005 LM4005 The product is intended for the quantitative in vitro determination of Lithium in serum. NDW Assay, Porphyrin, Spectrophotometry, Lithium 2 Li 2
24 05055273209020 LAN4216 JJY Multi-Analyte Controls, All Kinds (Assayed) 1 LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM – LEVEL 2 (LIQ CHEM ASY PREMIUM 2)
25 05055273208498 CH8312 MRR System, Test, Low Density, Lipoprotein 1 DIRECT LDL-CHOLESTEROL (LDL)
26 05055273208481 CH8311 For the quantitative in vitro determination of HDL Cholesterol in serum and plasma. LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl 1 DIRECT HDL-CHOLESTEROL (HDL)
27 05055273208467 CH8033 LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl 1 DIRECT HDL-CHOLESTEROL (HDL)
28 05055273208450 CH8032 MRR System, Test, Low Density, Lipoprotein 1 DIRECT LDL-CHOLESTEROL (LDL)
29 05055273208412 CH1383 Enzymatic Clearance assay for the in vitro quantitative determination of HDL-cho Enzymatic Clearance assay for the in vitro quantitative determination of HDL-cholesterol in human serum and plasma. LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl 1 DIRECT HDL-CHOLESTEROL (HDL)
30 05055273208047 DA4011 DA4011 The Cocaine assay is an in vitro diagnostic test for the qualitative and semi-qu The Cocaine assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzoylecgonine (Cocaine Metabolite) in human urine. DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites 2 BZG
31 05055273207958 DA3127 DA3127 The Randox Cannabinoid Control - Level 1 is intended for use in the Quality Cont The Randox Cannabinoid Control - Level 1 is intended for use in the Quality Control of the 11-nor-Δ9-THC-9-COOH (Cannabinoid) assay. The Cannabinoid Control Level 1 contains the specific drug Cannabinoid. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 THC CONTROL 1
32 05055273207330 IAS3118 This product is intended for in vitro diagnostic use, in the quality control of This product is intended for in vitro diagnostic use, in the quality control of the accuracy of Immunoassays on clinical chemistry systems. Thismaterial can be used to monitor the control of accuracy or the control of reproducibility of immunoassays. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 IMMUNOASSAY SPECIALITY II - LEVEL 2 (IA SPECIALITY II LEV 2)
33 05055273207880 DA2704 DA2704 The Randox Multidrug Calibrator Set is intended for use in the calibration of Me The Randox Multidrug Calibrator Set is intended for use in the calibration of Methamphetamine, Barbiturates, Cocaine Metabolite, Methadone and Opiate assays. DKB,DLJ Calibrators, Drug Mixture,Calibrators, Drug Specific 2 DOA CAL
34 05055273207866 DA2702 DA2702 The Randox EDDP Calibrator Set is intended for use in the calibration of the 2-e The Randox EDDP Calibrator Set is intended for use in the calibration of the 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) assay. DKB Calibrators, Drug Mixture 2 EDDP CAL
35 05055273207781 RX4041 RX4041 The Randox RX daytona plus without ISE is a fully automated, random access, clin The Randox RX daytona plus without ISE is a fully automated, random access, clinical chemistry analyser completewith dedicated analyser software. JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1 RX daytona plus
36 05055273207774 RX4040 RX4040 The Randox RX daytona plus with ISE is a fully automated, random access, clinica The Randox RX daytona plus with ISE is a fully automated, random access, clinical chemistry analyser completewith dedicated analyser software. JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1 RX daytona plus
37 05055273207644 CG5023 JJY Multi-Analyte Controls, All Kinds (Assayed) 1 COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)
38 05055273207262 IA3110 This product is intended for in vitro diagnostic use, as assayed quality control This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 IMMUNOASSAY PREMIUM PLUS - LEVEL 2 (IA PREMIUM PLUS 2)
39 05055273207248 LIA3108 The Randox Liquid Immunoassay Premium - Tri-Level are liquid controls developed The Randox Liquid Immunoassay Premium - Tri-Level are liquid controls developed for use in the quality control of quantitative assays statedin this package insert. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 LIQUID IMMUNOASSAY PREMIUM - TRI-LEVEL (LIQ IA PREMIUM 1, 2 AND 3)
40 05055273206456 TD3414 TD3414 For the quantitative in vitro determination of Valproic Acid in human serum LEG Enzyme Immunoassay, Valproic Acid 2 VPA
41 05055273206173 SE1086 OHQ Multi-Analyte Controls Unassayed 1 BOVINE PRECISION MULTI SERA - LEVEL 3 (BOV PREC CONTROL 3)
42 05055273206111 SA3854 SA3854 This product should be used in conjunction with RX series reagents to dilute sam This product should be used in conjunction with RX series reagents to dilute samples prior to assay JJF Analyzer, Chemistry, Micro, For Clinical Use 1 NS
43 05055273205091 RP3857 RP3857 The Reagent Precision Test is used on the RX series clinical chemistry systems f The Reagent Precision Test is used on the RX series clinical chemistry systems for checking proper functioning of the reagent fluid metering and photometric measuring system. JJF Analyzer, Chemistry, Micro, For Clinical Use 1 RABS
44 05055273204315 LO3998 GTQ Antistreptolysin - Titer/Streptolysin O Reagent 1 ANTI-STREPTOLYSIN-O 2 (ASO 2)
45 05055273204049 IT2692 IT2692 Liquid Protein Calibrators are an in vitro diagnostic product used for the calib Liquid Protein Calibrators are an in vitro diagnostic product used for the calibration of Alpha-1-Antitrypsin, Alpha-1-Acid glycoprotein, IgA, IgG and IgM assays that require sample pre-dilution. JIX Calibrator, Multi-Analyte Mixture 2 SP CAL (LIQ)
46 05055273204032 IT2691 IT2691 Liquid Protein Calibrators are an in vitro diagnostic product used for the calib Liquid Protein Calibrators are an in vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, Ceruloplasmin, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, RF and Transferrin assays. JIX Calibrator, Multi-Analyte Mixture 2 SP CAL (LIQ)
47 05055273203783 HN1530 The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target valu The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the analytes listed in the values section at both levels. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 HUMAN ASSAYED MULTI-SERA/ASSAYED CHEMISTRY PREMIUM PLUS - LEVEL 2 (HUM ASY CONTR
48 05055273202458 EV3550 EV3550 Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in the calibration of the Randox Drugs of Abuse Panel on the Evidence® analyser. DKB Calibrators, Drug Mixture 2 DOA CAL
49 05055273202397 EV3542 EV3542 The Evidence® Drugs of Abuse (DOA) Assays are in-vitro diagnostic tests for the The Evidence® Drugs of Abuse (DOA) Assays are in-vitro diagnostic tests for the qualitative determination of the parent molecule and metabolites of drugs in human urine. They are competitive enzyme immunoassays. DIO,DJR,DKZ,DIS,JXM,LDJ,DJG,LCM Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Methadon Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Amphetamine,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Phencyclidine 2 DOA
50 05055273202335 EV3529 EV3529 Chemiluminescent substrate comprised of 1 bottle of Luminol Reagent - EV805 and Chemiluminescent substrate comprised of 1 bottle of Luminol Reagent - EV805 and 1 bottle of Peroxide Reagent. The analyser uses a 1:1 mixture of the two solutions as a working signal reagent to generate a chemiluminescent signal which can be detected by the imaging module of the Evidence™ analyser. JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1 REAG SGNL - EV805
Other products with the same Product Code "CGX"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 15099590233525 472525 472525 SYNCHRON Systems Creatinine Reagent Synchron BECKMAN COULTER, INC.
2 15099590203344 A40920 A40920 Creatinine Reagent (CR-S 2 x 300) Synchron BECKMAN COULTER, INC.
3 15099590060077 OSR6678 Creatinine AU BECKMAN COULTER, INC.
4 15099590010737 OSR6178 Creatinine AU BECKMAN COULTER, INC.
5 07613336121177 08057532190 08057532190 Creatinine Jaffe Gen.2 ROCHE DIAGNOSTICS GMBH
6 05060500091873 VI560-1200 VI560-1200 Creatinine Reagent 4 X 67 mL + 4 X 67 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
7 05060500090784 VI562-L VI562-L Creatinine Picrate Reagent 6 X 500 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
8 05060500090777 VI561-L VI561-L Creatinine Decolorizing Reagent 6 X 500 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
9 05060500090760 VI560-911 VI560-911 Creatinine Reagent 4 X 50 mL + 4 X 50 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
10 05060500090753 VI560-WK VI560-WK Creatinine Reagent 3 X 25 mL + 3 X 25 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
11 05060500090746 VI5600-X VI5600-X Creatinine Reagent 1 X 250 mL + 1 X 250 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
12 05060500090739 VI560-R VI560-R Creatinine Reagent 3 X 250 mL + 3 X 250 mL Synermed® INFRARED LABORATORY SYSTEMS LLC
13 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
14 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
15 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
16 05055273201901 CR510 CR510 CREATININE (CREA) RANDOX LABORATORIES LIMITED
17 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
18 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
19 04015630930777 6407137190 6407137190 Creatinine Jaff Gen2 ROCHE DIAGNOSTICS GMBH
20 04015630926824 5401755190 5401755190 Creatinine Jaff Gen2 compensated) ROCHE DIAGNOSTICS GMBH
21 04015630922284 4810716190 4810716190 Creatinine Jaff Gen2 ROCHE DIAGNOSTICS GMBH
22 04015630918355 11929941216 11929941216 Creatinine Jaff method ROCHE DIAGNOSTICS GMBH
23 04015630910762 11875663216 11875663216 Creatinine Jaff method ROCHE DIAGNOSTICS GMBH
24 04015630910427 11875418216 11875418216 Creatinine Jaff method ROCHE DIAGNOSTICS GMBH
25 03610230006955 1300023842 Yumizen C1200 Creatinine Jaffé HORIBA ABX SAS
26 03610230005736 1220001933 ABX PENTRA CREATININE 120 CP HORIBA ABX SAS
27 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.
28 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.
29 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.
30 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.
31 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.
32 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.
33 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.
34 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.
35 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.
36 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.
37 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.
38 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.
39 00857969006112 SA1012 SA1012 Creatinine Reagent ACE ALFA WASSERMANN, INC.
40 00857969006068 RX1012 RX1012 Creatinine Reagent ACE ALFA WASSERMANN, INC.
41 00852169008126 CRE1120 CRE1120 In Vitro Diagnostics testing kit R1:3X50mL, R2:3X10mL ClearChem Diagnostics Inc. Creatinine (Jaffe) CLEARCHEM DIAGNOSTICS INC.
42 00851445007181 GEN-CREA R2(Acid) GEN-CREA R2(Acid) 10/17/2022 GENCHEM™ Creatinine Test Reagent GENCHEM INC
43 00851445007174 GEN-CREA R1(Base) GEN-CREA R1(Base) 10/17/2022 GENCHEM™ Creatinine Test Reagent GENCHEM INC
44 00845275003031 TR35121 Thermo Scientific Infinity™ FISHER DIAGNOSTICS
45 00817302024326 CC448 CC448 CREATININE CHECK CAROLINA LIQUID CHEMISTRIES CORP.® CREATININE CHECK REAGENT KIT CC448 CAROLINA LIQUID CHEMISTRIES CORPORATION
46 00817302020564 88809 88809 CREA3 (Creatinine) - Modular & CX3 Reagent 3 x 2000 mL CAROLINA LIQUID CHEMISTRIES CORP.® CREATININE REAGENT KIT 88809 CAROLINA LIQUID CHEMISTRIES CORPORATION
47 00817302020557 CC243 CC243 CREA (Creatinine) 2 x 300 tests CAROLINA LIQUID CHEMISTRIES CORP.® CREA CREATININE REAGENT CC243 CAROLINA LIQUID CHEMISTRIES CORPORATION
48 00817302020540 AU-243 AU-243 CREA (Creatinine) 3 x 300 tests CAROLINA LIQUID CHEMISTRIES CORP.® CREA RGT. KIT AU-243 CAROLINA LIQUID CHEMISTRIES CORPORATION
49 00817274022337 OCRE2-50 OCRE2-50 CREATININE (5 x 50mL) JAS Diagnostics DREW SCIENTIFIC, INC.
50 00817274021460 CRES-3U CREATININE STANDARD (1x 3mL) Unlabeled Vial JAS Diagnostics DREW SCIENTIFIC, INC.