Devices

Vitros

Model / Serial
All Vitros ECi units currently on the market (software version 3.1 or lower).
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide and worldwide distribution of the VITROS ECi Immunodiagnostic systems.
Product Description
Vitros ECi Immunodiagnostic System, sold as Cat. #863 3893; Cat. #192 2814 (Vitros ECiQ), and Cat. #680 1059 (recertified Vitros ECi) when using Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs. NOTE: These 3 catalog numbers of Vitros ECi represent the original unit, an updated unit with cosmetic changes only, and refurbished units.
Manufacturer
Ortho-Clinical Diagnostics
1 Event
- Recall of Vitros

Manufacturer

Ortho-Clinical Diagnostics

Manufacturer Address
Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
Source
USFDA

888 devices with a similar name

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VITROS Intact PTH Reagent and Calibrator

Model / Serial
6802892, 6802893 | 0700 (Expiry 18-Oct-16), 0710 (Expiry 14-Nov-16), 0728 (Expiry 12-Dec-16), 0738 (Expiry 02-Jan-17), 0748 (Expiry 06-Feb-17), 0758 (Expiry 06-Mar-17), 0768 (Expiry 10-Apr-17), and: see FSNs
Product Description
IVD: Intact parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
Manufacturer
Ortho Clinical Diagnostics

VITROS 3600

Model / Serial
6802783 | 3.0 and Below
Product Description
IVD: Immunoassay analyser Clinical chemistry analyser
Manufacturer
Ortho Clinical Diagnostics Inc.

Vitros 4600

Model / Serial
6802445 | 3.0 and Below
Product Description
IVD: Immunoassay analyser Clinical chemistry analyser
Manufacturer
Ortho Clinical Diagnostics Inc.

VITROS 5600

Model / Serial
6802413 | 3.0 and Below
Product Description
IVD: Immunoassay analyser Clinical chemistry analyser
Manufacturer
Ortho Clinical Diagnostics Inc.

Vitros 4600

Model / Serial
6802445 | 3.0 & Below
Product Description
IVD: Clinical chemistry analyser
Manufacturer
Ortho Clinical Diagnostics Inc.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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