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Architect

FDA UDI

Class N (US FDA UDI)

by Abbott Ireland Diagnostics

Identity

Trade Name
ARCHITECT FDA UDI
Generic Name
SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
AdviseDx SARS-CoV-2 IgM Reagent Kit 100 Test FDA UDI
Model / Reference
06R8720 FDA UDI
Description
AdviseDx SARS-CoV-2 IgM Reagent Kit 100 Test FDA UDI

Identifiers

Catalog Number
06R8720 FDA UDI
Primary DI / UDI-DI
00380740191863 FDA UDI
FDA Product Code
QKO FDA UDI
GMDN Term
SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
N 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

No

FDA UDI

Category: SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Architect by Abbott Ireland Diagnostics — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Ireland Diagnostics

Sources (1)

  • FDA UDI e71f76d6-fb6d-467f-b184-3ad5b84234d1 36 fields · synced Jun 1, 2026