Identity
- Trade Name
- Procalcitonin (PCT) Bi-Level Controls FDA UDI
- Generic Name
- Procalcitonin (PCT) IVD, control FDA UDI
- Device Name
- The Stanbio Procalcitonin (PCT) Control Set is intended for use as quality control in examining the accuracy and precision of the quantitative Stanbio Procalcitonin (PCT) LiquiColor® Assay. FDA UDI
- Model / Reference
- 2320-203 FDA UDI
- Description
- The Stanbio Procalcitonin (PCT) Control Set is intended for use as quality control in examining the accuracy and precision of the quantitative Stanbio Procalcitonin (PCT) LiquiColor® Assay. FDA UDI
Identifiers
- Catalog Number
- 2320-203 FDA UDI
- Primary DI / UDI-DI
- 00657498001974 FDA UDI
- FDA Product Code
- PTF FDA UDI
- GMDN Term
- Procalcitonin (PCT) IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3215 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Procalcitonin (PCT) Bi-Level Controls by Stanbio Laboratory, L.p. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Stanbio Laboratory, L.p.
Sources (1)
- FDA UDI 95d04226-f658-4e7a-81a6-7bdbd7b35056 37 fields · synced May 30, 2026