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B.R.A.H.M.S PCT sensitive KRYPTOR QC
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 082592N
Identity
- Trade Name
- B·R·A·H·M·S PCT sensitive KRYPTOR QC EUDAMEDB.R.A.H.M.S PCT sensitive KRYPTOR QC FDA UDI
- Generic Name
- Procalcitonin (PCT) IVD, control FDA UDI
- Device Name
- B·R·A·H·M·S PCT sensitive KRYPTOR QC EUDAMED
- Model / Reference
- 082592N EUDAMED82592 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260157631465 EUDAMED04260157632882 FDA UDI
- Basic UDI-DI
- 426015763825BPCTseKQCXXQD EUDAMED
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0102152099 CONTROLS- IMMUNOCHEMISTRY - OTHER EUDAMED
- GMDN Term
- Procalcitonin (PCT) IVD, control FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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, control
B.R.A.H.M.S PCT sensitive KRYPTOR QC by B.R.A.H.M.S GmbH — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Procalcitonin (PCT) IVD, control.
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- Elecsys PCT CalCheck 5 — Roche Diagnostics Corp. · Class I
- Alinity — Abbott Ireland Diagnostics · Class I
- Atellica IM PCT QC — Siemens Healthcare Diagnostics · 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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- B.R.A.H.M.S GmbH
Sources (2)
- FDA UDI 41e4ead5-e78e-481f-be22-078b3aaf2c7b 32 fields · synced Jul 26, 2026
- EUDAMED 1d5dfbca-7579-4819-a5f5-fe3b3fa9b893 61 fields · synced Jul 26, 2026