← Back to catalogue

Architect

FDA UDI

Class I (US FDA UDI)

by Abbott

Identity

Trade Name
ARCHITECT FDA UDI
Generic Name
Hepatitis A virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
ARCHITECT HAVAB-G Reagent Kit FDA UDI
Model / Reference
6L27-25 FDA UDI
Description
ARCHITECT HAVAB-G Reagent Kit FDA UDI

Identifiers

Catalog Number
06L2725 FDA UDI
Primary DI / UDI-DI
00380740011185 FDA UDI
510(k) Number
K113704 FDA UDI
FDA Product Code
MJY FDA UDI
JIS FDA UDI
LOL FDA UDI
MJX FDA UDI
GMDN Term
Hepatitis A virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
862.1150 FDA UDI
866.3310 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 A virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Architect by Abbott — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hepatitis A virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K113704 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Abbott

Sources (1)

  • FDA UDI 194576e6-0b30-4315-a0ab-57ad5ed1c3d3 37 fields · synced May 31, 2026