Other products from "ARKRAY USA, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00015482740504 740050 Blood Glucose Test Strips CGA GLUCOSE OXIDASE, GLUCOSE GLUCOCARD® 01 BLOOD GLUCOSE TEST STRIPS
2 00015482183103 18310 Dry Chemistry Analyzer IVD, semi-automated CGA GLUCOSE OXIDASE, GLUCOSE 2 SPOTCHEM™ EZ Analyzer
3 00015482771195 77119 Strip Description:  For the in vitro quantitative determination of magnesium con Strip Description:  For the in vitro quantitative determination of magnesium concentration in human plasma from whole blood samples. JGJ PHOTOMETRIC METHOD, MAGNESIUM SPOTCHEM™ II Magnesium
4 00015482771089 77108 Strip Description:  For the in vitro quantitative determination of total protein Strip Description:  For the in vitro quantitative determination of total protein in human plasma from whole blood samples. CIX BROMCRESOL GREEN DYE-BINDING, ALBUMIN SPOTCHEM™ II Total Protein
5 00015482771065 77106 Strip Description:  For the in vitro quantitative determination of total bilirub Strip Description:  For the in vitro quantitative determination of total bilirubin concentration in human plasma from whole blood samples. CIX BROMCRESOL GREEN DYE-BINDING, ALBUMIN SPOTCHEM™ II Total Bilirubin
6 00015482771034 77103 Strip Description:  For the in vitro quantitative determination of total cholest Strip Description:  For the in vitro quantitative determination of total cholesterol in human plasma from whole blood samples. CHH ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL SPOTCHEM™ II Total Cholesterol
7 00015482720506 720050 Blood Glucose Test Strips CGA GLUCOSE OXIDASE, GLUCOSE GLUCOCARD® 01 BLOOD GLUCOSE TEST STRIPS
8 00015482540050 540005 GLUCOCARD Shine Level 1 Control Solution contains a specific amount of glucose t GLUCOCARD Shine Level 1 Control Solution contains a specific amount of glucose that is used to check the performance of the meter and test strips. The test results you obtain should fall within the control solution range printed on the vial of test strips. (Primary UPC# 015482540050 is used as the assigned UDI for the Class I device.) JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 GLUCOCARD® Shine Level 1 Control Solution
9 00015482502959 250295 Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries. MEG Syringe, Antistick 2 ASSURE® ID Safety Syringe .5mL 29G x 1/2"
10 00015482275310 275131 Insulin Safety Pen Needle. Intended to be used with a pen injector device for t Insulin Safety Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, Hypodermic, Single Lumen Assure® ID Safety Pen Needle 5mm x 31g 100's
11 00015482129743 102974 Urine Analyzer utilize reflectance technology with  with AUTION Strips reagent t Urine Analyzer utilize reflectance technology with  with AUTION Strips reagent to provide qualitative or semiquantitative urine chemistry results.  Refractometery is used for specific gravity measurements, light transmission for color, and light scatter for turbidity. JMT,JIN,JRE,JIR,JJB,JIO,KQO,CEN,CDM,JIL,LJX DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT),NITROPRUSSIDE, KETONES (URINA DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT),NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.),REFRACTOMETER FOR CLINICAL USE,INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.),AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.),BLOOD, OCCULT, COLORIMETRIC, IN URINE,AUTOMATED URINALYSIS SYSTEM,DYE-INDICATOR, PH (URINARY, NON-QUANT.),DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.),METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE),TEST, URINE LEUKOCYTE 1 AUTION™ MAX AX-4022 Analyzer
12 30015482571994 571199 Retail: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU CGA,NBW GLUCOSE OXIDASE, GLUCOSE,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER 2 GLUCOCARD® Expression™ Blood Glucose Monitoring System
13 30015482571888 571188 DME: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU NBW,CGA SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,GLUCOSE OXIDASE, GLUCOSE 2 GLUCOCARD® Expression™ Blood Glucose Monitoring System
14 04987486738060 73806 Aution AU Control Solution is supplied in 2 different levels (High and Low) and Aution AU Control Solution is supplied in 2 different levels (High and Low) and is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry model. (Primary UPC/EAN-13# 4987486738060 is used as the assigned UDI for the Class I device.) JJW Urinalysis Controls (Assayed And Unassayed) 1 Aution™ AU Control Solution
15 04987486001973 100675 The ADAMS A1c HA-8180V system is intended for the quantitative determination of The ADAMS A1c HA-8180V system is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood and hemolysate samples using Ion Exchange high performance liquid chromatography (HPLC). PDJ Hemoglobin A1c Test System 2 ADAMS™ A1c HA-8180V (UL) Analyzer
16 00015482230296 230129 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, hypodermic, single lumen TechLITE PEN NEEDLES
17 00015482571108 571100 Portable Blood Glucose Meter NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER GLUCOCARD® EXPRESSION Blood Glucose Monitoring System
18 00015482771225 77122 Strip Description:  For the in vitro quantitative determination of HDL-Cholester Strip Description:  For the in vitro quantitative determination of HDL-Cholesterol in human plasma from whole blood samples. CHH ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL SPOTCHEM™ II HDL-Cholesterol
19 00015482771201 77120 Strip Description:  For the in vitro quantitative determination of lactate dehyd Strip Description:  For the in vitro quantitative determination of lactate dehydrogenase (LDH) activity in human plasma from whole blood samples. CFH TETRAZOLIUM INT DYE-DIAPHORASE, LACTATE DEHYDROGENASE SPOTCHEM™ II LDH
20 00015482771119 77111 Strip Description:  For the in vitro quantitative determination of ALT (alanine Strip Description:  For the in vitro quantitative determination of ALT (alanine aminotransferease or glutamic pyruvic transaminase) activity in human plasma from whole blood samples. CGA GLUCOSE OXIDASE, GLUCOSE SPOTCHEM™ II ALT / GPT
21 00015482761103 761100 Portable Blood Glucose Meter with Test Strips NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER 2 GLUCOCARD® Vital™ BLOOD GLUCOSE METER
22 00015482760205 760020 Portable Blood Glucose Meter NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER 2 GLUCOCARD® Vital™ BLOOD GLUCOSE METER
23 00015482760014 760001 Portable Blood Glucose Meter NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER 2 GLUCOCARD® Vital™ BLOOD GLUCOSE METER
24 00015482570101 570001 Portable Blood Glucose Meter NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER GLUCOCARD® EXPRESSION Blood Glucose Monitoring System
25 00015482544102 544110 The GLUCOCARD Shine Express Blood Glucose Monitoring System is intended for the The GLUCOCARD Shine Express Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf. NBW System, Test, Blood Glucose, Over The Counter 2 GLUCOCARD® Shine Express Blood Glucose Monitoring System
26 00015482542108 542110 The GLUCOCARD Shine XL Blood Glucose Monitoring System is intended for the quant The GLUCOCARD Shine XL Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf. NBW System, Test, Blood Glucose, Over The Counter 2 GLUCOCARD® Shine XL Blood Glucose Monitoring System
27 00015482541002 541100 The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantita The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The GLUCOCARD Shine Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neo nates and is not for the diagnosis or screening of diabetes. NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER GLUCOCARD® Shine Blood Glucose Monitoring System
28 00015482540012 540001 The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantita The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The GLUCOCARD Shine Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neo nates and is not for the diagnosis or screening of diabetes. NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER GLUCOCARD® Shine Blood Glucose Monitoring System
29 00015482530501 530050 / 530100 Blood Glucose Test Strips CGA GLUCOSE OXIDASE, GLUCOSE ASSURE® PRISM MULTI BLOOD GLUCOSE TEST STRIPS
30 00015482502300 502030 N/A Blood Glucose Test Strips. Assure Platinum Test Strips are intended for the qua Blood Glucose Test Strips. Assure Platinum Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood when used with the Assure Platinum Blood Glucose Meter. Testing is done outside the body (in vitro diognostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as a aid to monitor the effectiveness of diabetes control. CGA Glucose Oxidase, Glucose Assure® Platinum
31 00015482232290 232129 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, hypodermic, single lumen TechLITE PEN NEEDLES
32 00015482232993 232929 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, hypodermic, single lumen TechLITE PEN NEEDLES
33 00015482230999 230929 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, hypodermic, single lumen TechLITE PEN NEEDLES
34 00015482238919 238931 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, hypodermic, single lumen TechLITE PEN NEEDLES
35 00015482238322 238132 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, hypodermic, single lumen TechLITE PEN NEEDLES
36 00015482238315 238131 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, hypodermic, single lumen TechLITE PEN NEEDLES
37 00015482236328 236132 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, hypodermic, single lumen TechLITE PEN NEEDLES
38 00015482236311 236131 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, hypodermic, single lumen TechLITE PEN NEEDLES
39 00015482235918 235931 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, hypodermic, single lumen TechLITE PEN NEEDLES
40 00015482235314 235131 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of drugs. FMI Needle, Hypodermic, Single Lumen TechLITE PEN NEEDLES
41 00015482234928 234932 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, hypodermic, single lumen TechLITE PEN NEEDLES
42 00015482234324 234132 Insulin Pen Needle. Intended to be used with a pen injector device for the subc Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin. FMI Needle, hypodermic, single lumen TechLITE PEN NEEDLES
43 00015482145057 14505 Urine Analyzer utilize reflectance technology with  with AUTION Strips reagent t Urine Analyzer utilize reflectance technology with  with AUTION Strips reagent to provide qualitative or semiquantitative urine chemistry results.  Refractometery is used for specific gravity measurements, light transmission for color, and light scatter for turbidity. KQO AUTOMATED URINALYSIS SYSTEM 1 AUTION™ MAX AX-4030 Analyzer
44 30015482542994 542199 Startup Portable Blood Glucose Meter System. Includes: blood glucose meter, te Startup Portable Blood Glucose Meter System. Includes: blood glucose meter, test strips, IFU CGA,NBW Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter 2 GLUCOCARD® Shine XL Blood Glucose Monitoring System
45 30015482541997 541199 Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU CGA,NBW GLUCOSE OXIDASE, GLUCOSE,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER 2 GLUCOCARD® Shine Blood Glucose Monitoring System
46 04987486738107 73810 Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Cells, and Bacteria as well as flags for pathologic casts, yeast, crystal, small round cells, mucus, and sperm in urine sediment. KQO AUTOMATED URINALYSIS SYSTEM 1 AUTION™ Staining Solution BAC
47 04987486009801 102478 Aution Check Plus Controls is supplied in 2 different levels (2 bottles x 25mL o Aution Check Plus Controls is supplied in 2 different levels (2 bottles x 25mL of each level per box). They are supplied in liquid form, requiring no pretreatment or dilution. They are prepared by adding various compounds to human urine so that the desired reaction occurs during quality control. Preservatives have been added to prevent bacteria growth. (Primary UPC/EAN-13# 4987486009801 is used as the assigned UDI for the Class I device.) JJW Urinalysis Controls (Assayed And Unassayed) 1 AUTION Check Plus Controls
48 00015482771171 77117 Strip Description:  For the in vitro quantitative determination of fructosamine Strip Description:  For the in vitro quantitative determination of fructosamine in human plasma from whole blood samples. CGA GLUCOSE OXIDASE, GLUCOSE SPOTCHEM™ II Fructosamine
49 00015482771140 77114 Strip Description:  For the in vitro quantitative determination of GGT (y-glutam Strip Description:  For the in vitro quantitative determination of GGT (y-glutamyltransferase or y-glutamyl tanspeptidase, Y-GPT) activity in human plasma from whole blood samples. JPZ COLORIMETRIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE SPOTCHEM™ II GGT
50 30015482761999 761199 Retail: Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU CGA,NBW GLUCOSE OXIDASE, GLUCOSE,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER 2 GLUCOCARD® Vital™ Blood Glucose Monitoring System
Other products with the same Product Code "JIT"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 08426950907220 701351 1. QUANTA Flash Calprotectin Calibrator 1: Two (2) barcode labeled tubes contain 1. QUANTA Flash Calprotectin Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain recombinant calprotectin with stabilizers and preservatives. 2. QUANTA Flash Calprotectin Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain recombinant calprotectin with stabilizers and preservatives. 3. QUANTA Flash Calprotectin Calibrator 3: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain recombinant calprotectin with stabilizers and preservatives. QUANTA Flash® Calprotectin Calibrators INOVA DIAGNOSTICS, INC.
2 08426950845256 701341 1. QUANTA Flash RF IgM Calibrator 1: Two (2) barcode labeled tubes containing 0. 1. QUANTA Flash RF IgM Calibrator 1: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to RF IgM in stabilizers and preservatives.2. QUANTA Flash RF IgM Calibrator 2: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to RF IgM in stabilizers and preservatives. QUANTA Flash RF IgM Calibrators INOVA DIAGNOSTICS, INC.
3 08426950835196 701346 1. QUANTA Flash RF IgA Calibrator 1: Two (2) barcode labeled tubes containing 0. 1. QUANTA Flash RF IgA Calibrator 1: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to RF IgA in stabilizers and preservatives.2. QUANTA Flash RF IgA Calibrator 2: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to RF IgA in stabilizers and preservatives. QUANTA Flash RF IgA Calibrators INOVA DIAGNOSTICS, INC.
4 08426950793168 701331 1. QUANTA Flash HMGCR Calibrator 1: Two (2) barcode labeled tubes containing 0.3 1. QUANTA Flash HMGCR Calibrator 1: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to HMGCR in stabilizers and preservatives.2. QUANTA Flash HMGCR Calibrator 2: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to HMGCR in stabilizers and preservatives. QUANTA Flash® HMGCR Calibrators INOVA DIAGNOSTICS, INC.
5 08426950766988 701296 1. QUANTA Flash LKM-1 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 1. QUANTA Flash LKM-1 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to LKM-1 in stabilizers and preservatives.2. QUANTA Flash LKM-1 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to LKM-1 in stabilizers and preservatives.3. QUANTA Flash LKM-1 Calibrator 3: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to LKM-1 in stabilizers and preservatives. QUANTA Flash® Lkm-1 Calibrators INOVA DIAGNOSTICS, INC.
6 08426950729938 701301 1. QUANTA Flash M2 (MIT3) Calibrator 1: Two (2) barcode labeled tubes containing 1. QUANTA Flash M2 (MIT3) Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to M2 (MIT3) in stabilizers and preservatives.2. QUANTA Flash M2 (MIT3) Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to M2 (MIT3) in stabilizers and preservatives.3. QUANTA Flash M2 (MIT3) Calibrator 3: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to M2 (MIT3) in stabilizers and preservatives. QUANTA Flash® M2 (MIT3) Calibrators INOVA DIAGNOSTICS, INC.
7 08426950724490 701326 1. QUANTA Flash Scl-70 Calibrator 1: Two (2) barcode labeled tubes containing 0 1. QUANTA Flash Scl-70 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Scl-70 in stabilizers and preservatives. 2. QUANTA Flash Scl-70 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Scl-70 in stabilizers and preservatives. QUANTA Flash® Scl-70 Calibrators INOVA DIAGNOSTICS, INC.
8 08426950622185 701126 1. QUANTA Flash CCP3 Calibrator 1: Two (2) barcode labeled tubes containing 0.7 1. QUANTA Flash CCP3 Calibrator 1: Two (2) barcode labeled tubes containing 0.7 mL prediluted, ready to use reagent. Calibrators contain human antibodies to CCP3 in stabilizers and preservatives. 2. QUANTA Flash CCP3 Calibrator 2: Two (2) barcode labeled tubes containing 0.7 mL prediluted, ready to use reagent. Calibrators contain human antibodies to CCP3 in stabilizers and preservatives. QUANTA Flash® CCP3 Calibrators INOVA DIAGNOSTICS, INC.
9 08426950601913 701176 1. QUANTA Flash dsDNA Calibrator 1: Two (2) barcode labeled tubes containing 0.7 1. QUANTA Flash dsDNA Calibrator 1: Two (2) barcode labeled tubes containing 0.7 mL prediluted, ready to use reagent. Calibrators contain human antibodies to dsDNA in stabilizers and preservatives. 2. QUANTA Flash dsDNA Calibrator 2: Two (2) barcode labeled tubes containing 0.7 mL prediluted, ready to use reagent. Calibrators contain human antibodies to dsDNA in stabilizers and preservatives. QUANTA Flash® dsDNA Calibrators INOVA DIAGNOSTICS, INC.
10 08426950597049 701146 1. QUANTA Flash Ro60 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 1. QUANTA Flash Ro60 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Ro60 in stabilizers and preservatives. 2. QUANTA Flash Ro60 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Ro60 in stabilizers and preservatives. QUANTA Flash® Ro60 Calibrators INOVA DIAGNOSTICS, INC.
11 08426950596653 701261 1. QUANTA Flash Ro52 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 1. QUANTA Flash Ro52 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Ro52 in stabilizers and preservatives. 2. QUANTA Flash Ro52 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Ro52 in stabilizers and preservatives. QUANTA Flash® Ro52 Calibrators INOVA DIAGNOSTICS, INC.
12 08426950596264 701151 1. QUANTA Flash SS-B Calibrator 1: Two (2) barcode labeled tubes containing 0.3 1. QUANTA Flash SS-B Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to SS-B in stabilizers and preservatives. 2. QUANTA Flash SS-B Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to SS-B in stabilizers and preservatives. QUANTA Flash® SS-B Calibrators INOVA DIAGNOSTICS, INC.
13 08426950596028 701121 1. QUANTA Flash Sm Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL 1. QUANTA Flash Sm Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Sm in stabilizers and preservatives. 2. QUANTA Flash Sm Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Sm in stabilizers and preservatives. QUANTA Flash® Sm Calibrators INOVA DIAGNOSTICS, INC.
14 08426950595724 701161 1. QUANTA Flash Jo-1 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 1. QUANTA Flash Jo-1 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Jo-1 in buffer, stabilizers, and preservatives.2. QUANTA Flash Jo-1 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL, prediluted, ready to use reagent. Calibrators contain human antibodies to Jo-1 in buffer, stabilizers, and preservatives. QUANTA Flash® Jo-1 Calibrators INOVA DIAGNOSTICS, INC.
15 08426950595717 701116 1. QUANTA Flash RNP Calibrator 1: Two (2) barcode labeled tubes containing 0.3 m 1. QUANTA Flash RNP Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to RNP in stabilizers and preservatives. 2. QUANTA Flash RNP Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to RNP in stabilizers and preservatives. QUANTA Flash® RNP Calibrators INOVA DIAGNOSTICS, INC.
16 08058056682291 04Y85-01 04Y85-01 Lipase NG OC Cal must be used only for the calibration of Lipase NG. For In Vitr Lipase NG OC Cal must be used only for the calibration of Lipase NG. For In Vitro Diagnostic use. Lipase NG OC Cal SENTINEL CH. SPA
17 08058056681768 1665001 1665001 ACE Calibrator is intended to be used with Sentinel ACE Liquid Reagent for the p ACE Calibrator is intended to be used with Sentinel ACE Liquid Reagent for the preparation of the calibration for the kinetic determination of angiotensin converting enzyme (ACE) assay in human serum or plasma. For In Vitro Diagnostic use. ACE Calibrator SENTINEL CH. SPA
18 07613336191552 09315314190 09315314190 proBNP G2 CS Elecsys E2G V2.1 Elecsys proBNP II CalSet ROCHE DIAGNOSTICS GMBH
19 07613336191545 09315306190 09315306190 proBNP STAT CS Elecsys V2.1 Elecsys proBNP II STAT CalSet ROCHE DIAGNOSTICS GMBH
20 07613336191538 09315292190 09315292190 proBNP G2 CS Elecsys V2.1 Elecsys proBNP II CalSet ROCHE DIAGNOSTICS GMBH
21 07613336172667 09038116190 09038116190 Vitamin D total G3 CS Elecsys CalSet Vitamin D total III ROCHE DIAGNOSTICS GMBH
22 07613336171776 09013326190 09013326190 AMH CalSet ROCHE DIAGNOSTICS GMBH
23 07613336170397 08932417190 08932417190 FSH CalSet II ROCHE DIAGNOSTICS GMBH
24 07613336169315 07679866190 07679866190 CalSet Androstenedione ROCHE DIAGNOSTICS GMBH
25 07613336160336 08496641190 08496641190 CalSet Anti-TSHR ROCHE DIAGNOSTICS GMBH
26 07613336157664 08443459160 08443459160 TSH CalSet ROCHE DIAGNOSTICS GMBH
27 07613336148280 08250499160 08250499160 CalSet Troponin T Gen 5 ROCHE DIAGNOSTICS GMBH
28 07613336147696 08243930190 08243930190 CalSet PTH STAT ROCHE DIAGNOSTICS GMBH
29 07613336147689 08243891190 08243891190 CalSet II PTH ROCHE DIAGNOSTICS GMBH
30 07613336147672 08243875190 08243875190 CalSet PTH ROCHE DIAGNOSTICS GMBH
31 07613336143148 07475969190 07475969190 CalSet IGF-1 ROCHE DIAGNOSTICS GMBH
32 07613336142707 07574762190 07574762190 CalSet IGFBP-3 ROCHE DIAGNOSTICS GMBH
33 06944904084985 105-011385-00 Urine Standard (Indirect)(FDA) SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
34 06944904084978 105-011384-00 Serum Standard (Indirect)(FDA) SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
35 05700572014294 X0974 Cystatin C Calibrator Dako AGILENT TECHNOLOGIES SINGAPORE PTE LTD
36 05700572014287 X0973 Cystatin C Control Set Cystatin C Control Set AGILENT TECHNOLOGIES SINGAPORE PTE LTD
37 05700572013853 LX002 Cystatin C Immunoparticles Dako AGILENT TECHNOLOGIES SINGAPORE PTE LTD
38 05391516741866 450-11 450-11 Bile Acid Calibrator Set (5 x 5 mL) Trinity Biotech TRINITY BIOTECH PUBLIC LIMITED COMPANY
39 05391516741859 450-100 450-100 Bile Acid Calibrator 100 umol/l (5 mL) Trinity Biotech TRINITY BIOTECH PUBLIC LIMITED COMPANY
40 05055845400282 FHBC100/B08176 FHBC100/B08176 The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quan The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent AXIS-SHIELD DIAGNOSTICS LIMITED
41 05055845400169 FHRWR100 FHRWR100 The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quan The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit AXIS-SHIELD DIAGNOSTICS LIMITED
42 05055273216882 CYS10445 CYS10445 Intended for in vitro diagnostic (IVD) use in the calibration of Randox Cystatin Intended for in vitro diagnostic (IVD) use in the calibration of Randox Cystatin C assay. For use in a clinical laboratory setting by trained personnel. CYSTATIN C CALIBRATOR (CYSC CAL) RANDOX LABORATORIES LIMITED
43 05055273215557 TF10161 TF10161 The Randox Soluble Transferrin Receptors Calibrator Series is intended for use i The Randox Soluble Transferrin Receptors Calibrator Series is intended for use in the calibration of Soluble Transferrin Receptors assays. SOLUBLE TRANSFERRIN RECEPTORS CALIBRATOR SERIES (STFR CAL) RANDOX LABORATORIES LIMITED
44 05055273215540 HA8124 HA8124 The HbA1c II Calibrator is intended for use in the calibration of the HbA1c II assay. HbA1c II CALIBRATOR SET (HbA1c II CAL) RANDOX LABORATORIES LIMITED
45 05055273214550 SC10154 SC10154 This product is intended for in vitro diagnostic use, in the calibration of the This product is intended for in vitro diagnostic use, in the calibration of the Randox Ransel assay. RANSEL CALIBRATOR (RANSEL CAL) RANDOX LABORATORIES LIMITED
46 05055273213904 AO2800 ADIPONECTIN CALIBRATOR (ADPN CAL) RANDOX LABORATORIES LIMITED
47 05055273209204 LP5047 APOLIPOPROTEIN CALIBRATOR 2 (APO CAL 2) RANDOX LABORATORIES LIMITED
48 05055273208733 FR4030 FR4030 FRUCTOSAMINE (FRUC) RANDOX LABORATORIES LIMITED
49 05055273208436 CH5050 sLDL CALIBRATOR (sLDL CAL) RANDOX LABORATORIES LIMITED
50 05055273208405 CG5037 COAGULATION CALIBRATOR (COAG CAL) RANDOX LABORATORIES LIMITED