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 - 100 determinations FDA UDI
- Model / Reference
- RE21021 FDA UDI
- Description
- Acetylcholine Receptor Autoantibodies (ARAb) RRA Assay Kit - 100 determinations FDA UDI
Identifiers
- Catalog Number
- RE21021 FDA UDI
- Primary DI / UDI-DI
- 04049325001404 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 — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acetylcholine receptor antibody IVD, kit, radioimmunoassay.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- IBL International GmbH
Sources (1)
- FDA UDI 3e12bdb0-290b-40e7-b204-8a87376eb6c7 36 fields · synced May 30, 2026