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Elecsys Anti-HCV II

FDA UDI

Class U (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
Elecsys Anti-HCV II FDA UDI
Generic Name
Hepatitis C virus total antibody IVD, kit, chemiluminescent assay FDA UDI
Model / Reference
08837058162 FDA UDI

Identifiers

Catalog Number
08837058162 FDA UDI
Primary DI / UDI-DI
07613336183052 FDA UDI
FDA Product Code
QHM FDA UDI
GMDN Term
Hepatitis C virus total antibody IVD, kit, chemiluminescent assay FDA UDI

Classification

Device Class
U FDA UDI
Regulation Number
610.40 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

No

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

No

FDA UDI

Category: Hepatitis C virus total antibody IVD, kit, chemiluminescent assay

Elecsys Anti-HCV II by Roche Diagnostics Corp. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hepatitis C virus total antibody IVD, kit, chemiluminescent assay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA UDI 2db29ee6-9746-47da-a61d-b2c3dc0c25ea 33 fields · synced Jun 1, 2026