Product Classification / EMDN Category
FDA Product Code: JIT
Directory of devices assigned to product classification code JIT.
gudid
The Alere NT-proBNP for Alinity i Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of N-terminal pro B-type natriuretic peptide (NT-proBNP) in human serum and plasma.For additional information, refer to the Alere NT-proBNP for Alinity i reagent package insert and the Alinity ci-series Operations Manual.
Manufacturer: AXIS-SHIELD DIAGNOSTICS LIMITED
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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.
Manufacturer: AXIS-SHIELD DIAGNOSTICS LIMITED
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gudid
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.
Manufacturer: AXIS-SHIELD DIAGNOSTICS LIMITED
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gudid
1. Rivaroxaban Calibrator 1 (Cat. No. 0020015410): 5 x 1mL vials 2. Rivaroxaban Calibrator 2 (Cat. No. 0020015420) : 5 x 1mL vials
Manufacturer: INSTRUMENTATION LABORATORY COMPANY
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gudid
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.
Manufacturer: INOVA DIAGNOSTICS, INC.
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gudid
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.
Manufacturer: INOVA DIAGNOSTICS, INC.
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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.
Manufacturer: INOVA DIAGNOSTICS, INC.
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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.
Manufacturer: INOVA DIAGNOSTICS, INC.
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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.
Manufacturer: INOVA DIAGNOSTICS, INC.
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gudid
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.
Manufacturer: INOVA DIAGNOSTICS, INC.
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gudid
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.
Manufacturer: INOVA DIAGNOSTICS, INC.
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gudid
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.
Manufacturer: INOVA DIAGNOSTICS, INC.
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gudid
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.
Manufacturer: INOVA DIAGNOSTICS, INC.
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gudid
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.
Manufacturer: INOVA DIAGNOSTICS, INC.
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gudid
ACE Calibrator is intended to be used with ACE Reagent for the calibration of angiotensin converting enzyme (ACE) assay on Alinity c system. Use the CALIBRATOR according to the indicated analytical procedure. For In Vitro Diagnostic use. For laboratory professional use only.
Manufacturer: SENTINEL CH. SPA
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gudid
ACE Calibrator is intended to be used with ACE Reagent for the calibration of angiotensin converting enzyme (ACE) assay on ARCHITECT c System. Use the CALIBRATOR according to the indicated analytical procedure. For In Vitro Diagnostic use. For laboratory professional use only.
Manufacturer: SENTINEL CH. SPA
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gudid
Lipase NG OC Cal must be used only for the calibration of Lipase NG. For In Vitro Diagnostic use.
Manufacturer: SENTINEL CH. SPA
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gudid
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.
Manufacturer: SENTINEL CH. SPA
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gudid
Lp(a) Cal Set should be used as calibration curve for the Lp(a) Ultra test. Use the Calibrator according to the indicated analytical procedure.
Manufacturer: SENTINEL CH. SPA
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Urine Standard (Indirect)(FDA)
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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Serum Standard (Indirect)(FDA)
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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Testosterone Luminescence Immunoassay - 10 x 96 Determinations
Manufacturer: IBL International GmbH
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Testosterone Luminescence Immunoassay - 96 Determinations
Manufacturer: IBL International GmbH
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Urine Calibration Standard 1-Hydroxypyrene
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Plasma Calibration Standard Malondialdehyde
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Whole Blood Calibration Standard Glutathione
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Plasma Calibration Standard Coenzyme Q10
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Plasma Calibration Standard Homocysteine
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Serum Calibration Standard Levetiracetam
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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3PLUS1 Multilevel Plasma Calibrator Set MassChrom Methylmalonic Acid
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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3PLUS1 Multilevel Urine Calibrator Set MassChrom Methylmalonic Acid
Manufacturer: Chromsystems Instruments + Chemicals GmbH
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Tacrolimus Calibrator, Levels 1-5, 2 bottles each
Manufacturer: Siemens Healthcare Diagnostics Inc.
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HbA1c Kit containing Hemoglobin A1c Flex reagent cartridge, 240 tests, and HbA1c Calibrator (5 levels)
Manufacturer: Siemens Healthcare Diagnostics Inc.
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LOCI N-Terminal Pro-Brain Natriuretic Peptide Calibrator, 2x5x1mL
Manufacturer: Siemens Healthcare Diagnostics Inc.
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N-terminal Pro-Brain Natriuretic Peptide Calibrator, 2x6x1mL
Manufacturer: Siemens Healthcare Diagnostics Inc.
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The Stratus CS Acute Care NT-proBNP Calibrator (pBNP CalPak) is an in vitro diagnostic product intended to be used for the calibration of the Stratus CS Acute Care pBNP method.
Manufacturer: Siemens Healthcare Diagnostics Inc.
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Mass Creatine Kinase MB Isoenzyme Calibrator, 2x4x1mL / 2x2x1.5mL
Manufacturer: Siemens Healthcare Diagnostics Inc.
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N-Terminal Pro-Brain Natriuretic Peptide Calibrator, 2x5x1mL
Manufacturer: Siemens Healthcare Diagnostics Inc.
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Beta Human Chorionic Gonadotropin Calibrator, 2x4x1mL / 2x2mL / 2x1.5mL
Manufacturer: Siemens Healthcare Diagnostics Inc.
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Myoglobin Calibrator, 2x1.5mL / 2x2.5mL / 2x2.0mL
Manufacturer: Siemens Healthcare Diagnostics Inc.
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Urinary/Cerebrospinal Fluid Protein Calibrator, 3x1.5mL
Manufacturer: Siemens Healthcare Diagnostics Inc.
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Mass Creatine Kinase MB Isoenzyme Calibrator, 2x5x2mL
Manufacturer: Siemens Healthcare Diagnostics Inc.
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Calibration of Human a1-microglobulin and cystatin C assays on BN Systems
Manufacturer: Siemens Healthcare Diagnostics Products GmbH
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For the calibration of the C1IN method on the Dimension Vista System
Manufacturer: Siemens Healthcare Diagnostics Products GmbH
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Urinary / Cerebrospinal Fluid Protein Calibrator, 2x5x4mL
Manufacturer: Siemens Healthcare Diagnostics Inc.
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Revised C-Reactive Protein Calibrator, 2x5x1mL
Manufacturer: Siemens Healthcare Diagnostics Inc.
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gudid
The Stratus CS Acute Care NT-proBNP Dilution Pak (pBNP DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care pBNP TestPak on the Stratus CS analyzer for the measurement of samples with elevated levels of NT-proBNP.
Manufacturer: Siemens Healthcare Diagnostics Inc.
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gudid
The Stratus CS Acute Care Cardiac Troponin I Dilution Pak (cTNI DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care cTNI TestPak on the Stratus CS analyzer for the measurement of samples with elevated levels of cardiac Troponin I.
Manufacturer: Siemens Healthcare Diagnostics Inc.
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gudid
The Stratus CS Acute Care (TM) CKMB Calibrator (CKMB CalPak) is an in vitro diagnostic product intended to be used for the calibration of the Stratus CS Acute Care (TM) CKMB method.
Manufacturer: Siemens Healthcare Diagnostics Inc.
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gudid
HemosIL Apixaban Calibrators kit consists of:1. Apixaban Calibrator 1 (0020015210): 5 x 1 mL vials2. Apixaban Calibrator 2 (0020015220): 5 x 1 mL vials
Manufacturer: INSTRUMENTATION LABORATORY COMPANY
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