Identity
- Trade Name
- Kappa-APC FDA UDI
- Generic Name
- Kappa/lambda light chain immunoglobulin IVD, antibody FDA UDI
- Device Name
- Kappa-APC FDA UDI
- Model / Reference
- CYT-KAPPAP-A FDA UDI
- Description
- Kappa-APC FDA UDI
Identifiers
- Catalog Number
- CYT-KAPPAP-A FDA UDI
- Primary DI / UDI-DI
- 08436548983505 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Kappa/lambda light chain immunoglobulin IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Kappa/lambda light chain immunoglobulin IVD, antibody
Kappa-APC by Cytognos Sl — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Kappa/lambda light chain immunoglobulin IVD, antibody.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cytognos Sl
Sources (2)
- FDA UDI 121003f4-823c-4ed3-a485-3774e3e0a236 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026