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Vitros

FDA UDI

Class I (US FDA UDI)

by Ortho-Clinical Diagnostics

Identity

Trade Name
VITROS FDA UDI
Generic Name
Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
VITROS Immunodiagnostic Products LH Reagent Pack FDA UDI
Model / Reference
1350198 FDA UDI
Description
VITROS Immunodiagnostic Products LH Reagent Pack FDA UDI

Identifiers

Catalog Number
1350198 FDA UDI
Primary DI / UDI-DI
10758750008902 FDA UDI
FDA Product Code
CEP FDA UDI
GMDN Term
Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1485 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay

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

Similar devices

Also classified as Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay.

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 af6e4fac-6f69-454a-bcb1-2a409d8b298b 35 fields · synced Jun 1, 2026