Identity
- Trade Name
- DiaSys Procalcitonin FS FDA UDI
- Generic Name
- Procalcitonin (PCT) IVD, reagent FDA UDI
- Device Name
- Diagnostic reagent for quantitative in vitro determination of procalcitonin (PCT) in human serum or lithium heparin plasma FDA UDI
- Model / Reference
- 173189943018 FDA UDI
- Description
- Diagnostic reagent for quantitative in vitro determination of procalcitonin (PCT) in human serum or lithium heparin plasma FDA UDI
Identifiers
- Catalog Number
- 173189943018 FDA UDI
- Primary DI / UDI-DI
- 04051839013668 FDA UDI
- 510(k) Number
- K242294 FDA UDI
- FDA Product Code
- PTF FDA UDI
- GMDN Term
- Procalcitonin (PCT) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3215 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
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, reagent
DiaSys Procalcitonin FS by DiaSys Diagnostic Systems GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Procalcitonin (PCT) IVD, reagent.
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 II | Pending data |
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Manufacturer
- Manufacturer
- DiaSys Diagnostic Systems GmbH
Sources (1)
- FDA UDI c35ae106-4ec9-4448-8413-4e8ece10a250 36 fields · synced Jun 1, 2026