Identity
- Trade Name
- B.R.A.H.M.S PCT sensitive KRYPTOR CAL FDA UDI
- Generic Name
- Procalcitonin (PCT) IVD, calibrator FDA UDI
- Model / Reference
- 82591 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260157632875 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Procalcitonin (PCT) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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
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
No
FDA UDI
Category: Procalcitonin (PCT) IVD, calibrator
B.R.A.H.M.S PCT sensitive KRYPTOR CAL by B.R.A.H.M.S GmbH — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Procalcitonin (PCT) IVD, calibrator.
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- Lumipulse G BRAHMS PCT Calibrator Set — FUJIREBIO INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- B.R.A.H.M.S GmbH
Sources (2)
- FDA UDI 50ed23f6-15de-4cb3-8ce3-ed4f65811762 32 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026