Identity
- Trade Name
- TruLab Procalcitonin Bi-Level Controls FDA UDI
- Generic Name
- Procalcitonin (PCT) IVD, control FDA UDI
- Device Name
- TruLab Procalcitonin Bi-Level Controls are an assayed quality control material for monitoring the performance of quantitative in vitro determination of procalcitonin (PCT) for the DiaSys Procalcitonin FS assay FDA UDI
- Model / Reference
- 599809943086 FDA UDI
- Description
- TruLab Procalcitonin Bi-Level Controls are an assayed quality control material for monitoring the performance of quantitative in vitro determination of procalcitonin (PCT) for the DiaSys Procalcitonin FS assay FDA UDI
Identifiers
- Catalog Number
- 599809943086 FDA UDI
- Primary DI / UDI-DI
- 04051839013675 FDA UDI
- 510(k) Number
- K242294 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Procalcitonin (PCT) IVD, control 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, control
TruLab Procalcitonin Bi-Level Controls 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, control.
- LIAISON Controls BRAHMS PCT II GEN — Diasorin Inc.
- VITROS — Ortho-Clinical Diagnostics · Class II
- Atellica IM BRAHMS PCT QC Kit — Siemens Healthcare Diagnostics · Class I
- Audit MicroControls Linearity FD Procalcitonin bioMerieux VIDAS and miniVIDAS — Aalto Scientific, Ltd.
- Audit MicroControls Linearity FD Procalcitonin for Abbott Systems — Aalto Scientific, Ltd.
- Elecsys PCT CalCheck 5 — Roche Diagnostics Corp. · Class I
- Alinity — Abbott Ireland Diagnostics · Class I
- Atellica IM PCT QC — Siemens Healthcare Diagnostics · 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 896e6967-9b78-4e4d-a087-ccb037a1a9ee 36 fields · synced May 30, 2026