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Elecsys Anti-HCV II

FDA UDI

Class II (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
08836981190 FDA UDI

Identifiers

Catalog Number
08836981190 FDA UDI
Primary DI / UDI-DI
07613336166956 FDA UDI
510(k) Number
K221693 FDA UDI
FDA Product Code
MZO FDA UDI
GMDN Term
Hepatitis C virus total antibody IVD, kit, chemiluminescent assay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3169 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 II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K221693 also covers:

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 cb5ed8e8-c729-4c68-bb3c-03ed29c8359e 34 fields · synced May 30, 2026