Identity
- Trade Name
- TruCal Procalcitonin Calibrator Set FDA UDI
- Generic Name
- Procalcitonin (PCT) IVD, calibrator FDA UDI
- Device Name
- The TruCal Procalcitonin Calibrator Set is intended for in vitro use for calibration of the DiaSys Procalcitonin FS assay FDA UDI
- Model / Reference
- 173109943082 FDA UDI
- Description
- The TruCal Procalcitonin Calibrator Set is intended for in vitro use for calibration of the DiaSys Procalcitonin FS assay FDA UDI
Identifiers
- Catalog Number
- 173109943082 FDA UDI
- Primary DI / UDI-DI
- 04051839013682 FDA UDI
- 510(k) Number
- K242294 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Procalcitonin (PCT) IVD, calibrator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
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
TruCal Procalcitonin Calibrator Set by DiaSys Diagnostic Systems GmbH — Class I — 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
- Lumipulse G BRAHMS PCT Calibrator Set — FUJIREBIO INC. · Class II
Cleared under the same submission
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 I | Pending data |
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Manufacturer
- Manufacturer
- DiaSys Diagnostic Systems GmbH
Sources (1)
- FDA UDI 6169950f-97d6-4a81-ae01-8bd34638c6cd 36 fields · synced Jun 8, 2026