Identity
- Trade Name
- ANTISERA CAPI 3 IT (10) FDA UDI
- Generic Name
- Multiple clinical chemistry protein IVD, reagent FDA UDI
- Model / Reference
- 2601 FDA UDI
Identifiers
- Catalog Number
- 2601 FDA UDI
- Primary DI / UDI-DI
- 03607360026014 FDA UDI
- 510(k) Number
- K161928 FDA UDI
- FDA Product Code
- CFF FDA UDI
- GMDN Term
- Multiple clinical chemistry protein IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5510 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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: Multiple clinical chemistry protein IVD, reagent
Antisera Capi 3 It (10) by Sebia, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple clinical chemistry protein IVD, reagent.
- N Reaction Buffer — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- CAPI 3 IMMUNOTYPING — Sebia, Inc. · Class I
- CAPILLARYS IMMUNOTYPING — Sebia, Inc. · Class I
- Sample Diluent CAPI 3 IT (10) — Sebia, Inc. · Class II
Cleared under the same submission
K161928 also covers:
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
- Sebia, Inc.
Sources (1)
- FDA UDI cd178ff2-5269-422f-97af-1d519925048d 35 fields · synced May 30, 2026