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Ortho-Clinical Diagnostics, Inc.

71 FDA actions

VITROS Immunodiagnostic Products hs Troponin I Reagent Pack

Ortho-Clinical Diagnostics, Inc.

VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a

Ortho-Clinical Diagnostics, Inc.

Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total o

Ortho-Clinical Diagnostics, Inc.

VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;

Ortho-Clinical Diagnostics, Inc.

Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Num

Ortho-Clinical Diagnostics, Inc.

Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Nu

Ortho-Clinical Diagnostics, Inc.

VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);

Ortho-Clinical Diagnostics, Inc.

VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);

Ortho-Clinical Diagnostics, Inc.

VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package c

Ortho-Clinical Diagnostics, Inc.

Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; S

Ortho-Clinical Diagnostics, Inc.

Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software

Ortho-Clinical Diagnostics, Inc.

Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915

Ortho-Clinical Diagnostics, Inc.

Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software

Ortho-Clinical Diagnostics, Inc.

VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 9

Ortho-Clinical Diagnostics, Inc.

Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certif

Ortho-Clinical Diagnostics, INc.

Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified

Ortho-Clinical Diagnostics, INc.

Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Cer

Ortho-Clinical Diagnostics, INc.

VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration

Ortho-Clinical Diagnostics, Inc.

The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein

Ortho-Clinical Diagnostics, Inc.

VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2

Ortho-Clinical Diagnostics, Inc.

VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the

Ortho-Clinical Diagnostics, Inc.

VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Produ

Ortho-Clinical Diagnostics, Inc.

VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibra

Ortho-Clinical Diagnostics, Inc.

VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calib

Ortho-Clinical Diagnostics, Inc.

VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)

Ortho-Clinical Diagnostics, Inc.

VITROS XT 7600 Integrated System, Catalog No. 6844461

Ortho-Clinical Diagnostics, Inc.

VITROS 5600 Integrated System (New and Refurbished)

Ortho-Clinical Diagnostics, Inc.

VITROS XT7600 Integrated System

Ortho-Clinical Diagnostics, Inc.

VITROS XT 3400 Chemistry System, Catalog No. 6844458

Ortho-Clinical Diagnostics, Inc.

VITROS 3600 Immunodiagnostic System (New and Refurbished)

Ortho-Clinical Diagnostics, Inc.

VITROS XT 7600 Integrated System, Catalog No. 6844461

Ortho-Clinical Diagnostics, Inc.

VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)

Ortho-Clinical Diagnostics, Inc.

VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)

Ortho-Clinical Diagnostics, Inc.

VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)

Ortho-Clinical Diagnostics, Inc.

VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)

Ortho-Clinical Diagnostics, Inc.

VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)

Ortho-Clinical Diagnostics, Inc.

VITROS XT 3400 Chemistry System, Catalog No. 6844458

Ortho-Clinical Diagnostics, Inc.

VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Prod

Ortho-Clinical Diagnostics, Inc.

QMS Tacrolimus Calibrators, Product code 10015573

Ortho-Clinical Diagnostics, Inc.

VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0

Ortho-Clinical Diagnostics, Inc.

VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0

Ortho-Clinical Diagnostics, Inc.

VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0

Ortho-Clinical Diagnostics, Inc.

VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0

Ortho-Clinical Diagnostics, Inc.

VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3

Ortho-Clinical Diagnostics, Inc.

VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitat

Ortho-Clinical Diagnostics, INc.

VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains

Ortho-Clinical Diagnostics, INc.

Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Che

Ortho-Clinical Diagnostics, Inc.

VITROS XT Chemistry Products ALKP Slides

Ortho-Clinical Diagnostics, INc.

VITROS XT Chemistry Products TBIL-ALKP Slides

Ortho-Clinical Diagnostics, INc.

VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the

Ortho-Clinical Diagnostics, Inc.

VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Dat

Ortho-Clinical Diagnostics, Inc.

VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (

Ortho-Clinical Diagnostics, Inc.

VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a

Ortho-Clinical Diagnostics, Inc.

VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement

Ortho-Clinical Diagnostics, Inc.

VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative

Ortho-Clinical Diagnostics, Inc.

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 To

Ortho-Clinical Diagnostics, Inc.

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG

Ortho-Clinical Diagnostics, Inc.

VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD

Ortho-Clinical Diagnostics, Inc.

VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid ho

Ortho-Clinical Diagnostics, Inc.

VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product C

Ortho-Clinical Diagnostics, Inc.

VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461

Ortho-Clinical Diagnostics, Inc.

VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458

Ortho-Clinical Diagnostics, Inc.

Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and V

Ortho-Clinical Diagnostics, Inc.

VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198

Ortho-Clinical Diagnostics, Inc

VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922

Ortho-Clinical Diagnostics, Inc

VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793

Ortho-Clinical Diagnostics, Inc

VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.

Ortho-Clinical Diagnostics, Inc.

VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack

Ortho-Clinical Diagnostics, Inc.

VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of t

Ortho-Clinical Diagnostics, Inc.

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance

Ortho Clinical Diagnostics Inc

VITROS Chemistry Products PHBR Slides

Ortho-Clinical Diagnostics, Inc.