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Architect

FDA UDI

Class II (US FDA UDI)

by Abbott

Identity

Trade Name
ARCHITECT FDA UDI
Generic Name
Hepatitis C virus total antibody IVD, kit, chemiluminescent assay FDA UDI
Device Name
ARCHITECT Anti-HCV Reagent Kit FDA UDI
Model / Reference
1L79-35 FDA UDI
Description
ARCHITECT Anti-HCV Reagent Kit FDA UDI

Identifiers

Catalog Number
01L7935 FDA UDI
Primary DI / UDI-DI
00380740001421 FDA UDI
PMA Number
P050042 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

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

No

FDA UDI

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

Architect by Abbott — 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

P050042 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott

Sources (1)

  • FDA UDI 00f8eeed-f8c2-4a7e-b3e1-1c210123aaf1 37 fields · synced Jun 8, 2026