International Medical Devices Database

Manufacturer Address
Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626-5101
Source
USFDA
3 Events

3 devices in the database

Device Recall VITROS 5,1 FS Chemistry System

Model / Serial
Software Version 2.2.1, Serial Numbers 34000121 to 34001377.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide and Worldwide
Product Description
VITROS¿ 5,1 FS (Fusion Series) Chemistry System Software Version 2.2.1, only when using VITROS¿ Chemistry Products THC (Cannabinoids) or AMPH (Amphetamine) Reagents, Cat. No. 680 1375.

VITROS Immunodiagnostic Products Troponin I Reagent Pack

Model / Serial
Lots 3151 and 3170
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide-including USA, Canada, and Bermuda
Product Description
VITROS¿ Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A Troponin Immunoassay Method, IVD. Ortho-Clinical Diagnostics, Amersham UK

VITROS Chemistry Products GLU DT Slides GEN 56

Model / Serial
REF 153 2316
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution
Product Description
VITROS¿ Chemistry Products GLU DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per box. VITROS¿ Chemistry Products GLU DT Slides quantitatively measure glucose (GLU) concentration in serum and plasma. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. .

53 manufacturers with a similar name

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Ortho-Clinical Diagnostics Inc

Manufacturer Parent Company (2017)
The Carlyle Group LP
Source
NZMMDSA

Ortho-Clinical Diagnostics European Support Centre

Manufacturer Parent Company (2017)
The Carlyle Group LP
Source
NZMMDSA

Ortho-Clinical Diagnostics c/- Johnson & Johnson

Manufacturer Parent Company (2017)
The Carlyle Group LP
Source
NZMMDSA

ORTHO-CLINICAL DIAGNOSTICS

Manufacturer Parent Company (2017)
The Carlyle Group LP
Source
MSHM

ORTHO-CLINICAL DIAGNOSTICS MARTA CARNIELLI

Manufacturer Parent Company (2017)
The Carlyle Group LP
Source
MSHM

48 more

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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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