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Acetylcholine Receptor Autoantibodies (ARAb) RRA

FDA UDIEUDAMED

Class II (US FDA UDI)

by IBL International GmbH

Identity

Trade Name
Acetylcholine Receptor Autoantibodies (ARAb) RRA FDA UDI
Generic Name
Acetylcholine receptor antibody IVD, kit, radioimmunoassay FDA UDI
Device Name
Acetylcholine Receptor Autoantibodies (ARAb) RRA Assay Kit - 30 determinations FDA UDI
Model / Reference
RE21023 FDA UDI
Description
Acetylcholine Receptor Autoantibodies (ARAb) RRA Assay Kit - 30 determinations FDA UDI

Identifiers

Catalog Number
RE21023 FDA UDI
Primary DI / UDI-DI
04049325001428 FDA UDI
FDA Product Code
NST FDA UDI
GMDN Term
Acetylcholine receptor antibody IVD, kit, radioimmunoassay 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

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: Acetylcholine receptor antibody IVD, kit, radioimmunoassay

Acetylcholine Receptor Autoantibodies (ARAb) RRA by IBL International GmbH — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Acetylcholine receptor antibody IVD, kit, radioimmunoassay.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
IBL International GmbH

Sources (2)

  • FDA UDI 60856917-d15a-4f54-af0d-0a2d1d9d5859 36 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 3, 2026