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Anti-Reticulin IgA Antibody(L) Test

FDA UDI

Class II (US FDA UDI)

by Scimedx Corp.

Identity

Trade Name
Anti-Reticulin IgA Antibody(L) Test FDA UDI
Generic Name
Multiple Coeliac disease-associated antibody IVD, control FDA UDI
Model / Reference
5796AL FDA UDI

Identifiers

Catalog Number
5796AL FDA UDI
Primary DI / UDI-DI
00813545022990 FDA UDI
FDA Product Code
DBL FDA UDI
GMDN Term
Multiple Coeliac disease-associated antibody IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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: Multiple Coeliac disease-associated antibody IVD, control

Anti-Reticulin IgA Antibody(L) Test by Scimedx Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple Coeliac disease-associated antibody IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scimedx Corp.

Sources (1)

  • FDA UDI 040af5b0-8258-467d-971b-d148918994b8 34 fields · synced May 30, 2026