Devices

Ortho Clinical Diagnostics VITROS Immunodiagnostic Products iPTH ReagentPack

Model / Serial
Lot / Expiry date: 1) 0700 (18 Oct 2016), 0710 (14 Nov 2016), 0748 (16 Feb 2017, 0758 (06 Mar 2017); 2) 0728 (12 Dec 2016), 0738 (02 Jan 2017), 0768 (10 Apr 2017)
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - Nationwide Distribution : and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
Product Description
VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892 - Reagent Pack, 2) UPN 10758750006250 / Product Code 6802893 - Calibrators || For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Intact PTH is indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively
Manufacturer
ORTHO-CLINICAL DIAGNOSTICS
1 Event
- Recall of Ortho Clinical Diagnostics VITROS Immunodiagnostic Products iPTH ReagentPack

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS

Manufacturer Address
ORTHO-CLINICAL DIAGNOSTICS, FELINDRE MEADOWS, Bridgend United Kingdom
Manufacturer Parent Company (2017)
The Carlyle Group LP
Source
USFDA

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