Identity
- Trade Name
- Lumipulse G BRAHMS PCT Calibrator Set FDA UDI
- Generic Name
- Procalcitonin (PCT) IVD, calibrator FDA UDI
- Model / Reference
- 234938 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987270234938 FDA UDI
- 510(k) Number
- K172713 FDA UDI
- FDA Product Code
- NTM FDA UDI
- GMDN Term
- Procalcitonin (PCT) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3210 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: Procalcitonin (PCT) IVD, calibrator
Lumipulse G BRAHMS PCT Calibrator Set by Fujirebio Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Procalcitonin (PCT) IVD, calibrator.
- Diazyme Procalcitonin Calibrator Set — Diazyme Laboratories, Inc.
- ARCHITECT — Abbott · Class I
- Alinity — Abbott Ireland Diagnostics · Class II
- ARCHITECT — Abbott · Class I
- DM EXL LOCI BRAHMS PCT Cal Kit — Siemens Healthcare Diagnostics · Class II
- B.R.A.H.M.S PCT sensitive KRYPTOR CAL — B.R.A.H.M.S GmbH · Class II
- TruCal Procalcitonin Calibrator Set — DiaSys Diagnostic Systems GmbH · Class I
Cleared under the same submission
K172713 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
- Fujirebio Inc.
Sources (1)
- FDA UDI 0b5c5b7c-85c7-4bca-85c0-e31486d0466a 36 fields · synced Jun 6, 2026