Identity
- Trade Name
- Kallestad FDA UDI
- Generic Name
- Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- Kallestad Crithidia luciliae Substrate FDA UDI
- Model / Reference
- 31069 FDA UDI
- Description
- Kallestad Crithidia luciliae Substrate FDA UDI
Identifiers
- Catalog Number
- 31069 FDA UDI
- Primary DI / UDI-DI
- 00847865001533 FDA UDI
- 510(k) Number
- K780899 FDA UDI
- FDA Product Code
- DHN FDA UDI
- GMDN Term
- Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5100 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
No
FDA UDI
Category: Native DNA antibody (anti-nDNA) 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 Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay.
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- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc. · Class II
- Fluorescent nDNA Test System — IMMUNO CONCEPTS INC
- IgG Anti-nDNA Fluorescent Test System — IMMUNO CONCEPTS INC
Cleared under the same submission
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
- Bio-Rad Laboratories
Sources (1)
- FDA UDI 4ba60cb8-9c19-41ef-bf67-7a18e4d00f48 38 fields · synced May 30, 2026