Identity
- Trade Name
- Kallestad FDA UDI
- Generic Name
- Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- Kallestad Anti-Neutrophil Cytoplasmic Antibodies (ANCA) Ethanol IFA FDA UDI
- Model / Reference
- 29403 FDA UDI
- Description
- Kallestad Anti-Neutrophil Cytoplasmic Antibodies (ANCA) Ethanol IFA FDA UDI
Identifiers
- Catalog Number
- 29403 FDA UDI
- Primary DI / UDI-DI
- 00847817016103 FDA UDI
- 510(k) Number
- K982898 FDA UDI
- FDA Product Code
- MOB FDA UDI
- GMDN Term
- Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
Kallestad by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay.
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- IFA: Granulocyte Mosaic 2 — EUROIMMUN Medizinische Labordiagnostika AG · Class II
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- IFA: Granulocyte Mosaic 13 EUROPattern — EUROIMMUN Medizinische Labordiagnostika AG · Class II
Cleared under the same submission
K982898 also covers:
- Kallestad — Bio-Rad Laboratories
- Kallestad ANCA — Bio-Rad Laboratories
- Kallestad ANCA — Bio-Rad Laboratories
- Kallestad ANCA — Bio-Rad Laboratories
- Kallestad ANCA — Bio-Rad Laboratories
- Kallestad ANCA — Bio-Rad Laboratories
- Kallestad ANCA — Bio-Rad Laboratories
- Kallestad ANCA — Bio-Rad Laboratories
- Kallestad ANCA — Bio-Rad Laboratories
- Kallestad ANCA — Bio-Rad Laboratories
- Kallestad ANCA — Bio-Rad Laboratories
- Kallestad ANCA — Bio-Rad Laboratories
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bio-Rad Laboratories
Sources (1)
- FDA UDI b3438cb1-1837-4871-a314-523fbf8b9fb7 38 fields · synced May 30, 2026