Identity
- Trade Name
- Kallestad FDA UDI
- Generic Name
- Multiple antinuclear antibody (ANA) screening IVD, reagent FDA UDI
- Device Name
- Kallestad HEp-2 Cell Line 6 Well Slides FDA UDI
- Model / Reference
- 26101 FDA UDI
- Description
- Kallestad HEp-2 Cell Line 6 Well Slides FDA UDI
Identifiers
- Catalog Number
- 26101 FDA UDI
- Primary DI / UDI-DI
- 00847865001625 FDA UDI
- 510(k) Number
- K810863 FDA UDI
- FDA Product Code
- DBM FDA UDI
- GMDN Term
- Multiple antinuclear antibody (ANA) screening IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5090 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
No
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: Multiple antinuclear antibody (ANA) screening IVD, reagent
Kallestad by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple antinuclear antibody (ANA) screening IVD, reagent.
- HEp-2000® IgG Fluorescent ANA-Ro Test System — IMMUNO CONCEPTS INC
- HEp-2000® IgG Fluorescent ANA-Ro Test System — IMMUNO CONCEPTS INC
- HEp-2000® IgG Fluorescent ANA-Ro Test System — IMMUNO CONCEPTS INC
- Immco Diagnostics — Immco Diagnostics, Inc. · Class II
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc. · Class II
- Colorzyme® ANA Test System — IMMUNO CONCEPTS INC
- R. KDY/STM Pack 4 WELL — Scimedx Corp. · Class II
- R. LVR/KDY/STM Pack 8 WELL — Scimedx Corp. · Class II
Cleared under the same submission
K810863 also covers:
- Bio-Rad Laboratories, Inc. — Bio-Rad Laboratories
- Bio-Rad Laboratories, Inc. — Bio-Rad Laboratories
- Bio-Rad Laboratories, Inc. — Bio-Rad Laboratories
- Bio-Rad Laboratories, Inc. — Bio-Rad Laboratories
- Kallestad — Bio-Rad Laboratories
- Kallestad — Bio-Rad Laboratories
- Kallestad — Bio-Rad Laboratories
- Kallestad — Bio-Rad Laboratories
- Kallestad — Bio-Rad Laboratories
- Kallestad — Bio-Rad Laboratories
- Kallestad — Bio-Rad Laboratories
- Kallestad — 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 |
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Manufacturer
- Manufacturer
- Bio-Rad Laboratories
Sources (1)
- FDA UDI 1cd8095a-71f7-4bb9-b43c-66ef80a8ee22 38 fields · synced Jun 1, 2026