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Vitros

FDA UDI

Class II (US FDA UDI)

by Ortho-Clinical Diagnostics

Identity

Trade Name
VITROS FDA UDI
Generic Name
Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack FDA UDI
Model / Reference
6900052 FDA UDI
Description
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack FDA UDI

Identifiers

Catalog Number
6900052 FDA UDI
Primary DI / UDI-DI
10758750032709 FDA UDI
510(k) Number
K221197 FDA UDI
FDA Product Code
CEW FDA UDI
GMDN Term
Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1545 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay

Vitros by Ortho-Clinical Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K221197 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ortho-Clinical Diagnostics

Sources (1)

  • FDA UDI 272d4c79-abd8-4cf1-a170-2a7a4584b35d 36 fields · synced May 30, 2026