Identity
- Trade Name
- BÜHLMANN fCAL® turbo Calibrator Kit FDA UDI
- Generic Name
- Calprotectin IVD, calibrator FDA UDI
- Device Name
- Calibrator kit for quantitative PETIA assay for the determination of calprotectin (MRP8/14) in human stool specimens FDA UDI
- Model / Reference
- B-KCAL-CASET FDA UDI
- Description
- Calibrator kit for quantitative PETIA assay for the determination of calprotectin (MRP8/14) in human stool specimens FDA UDI
Identifiers
- Primary DI / UDI-DI
- EBUHBKCALCASET0 FDA UDI
- GMDN Term
- Calprotectin IVD, calibrator FDA UDI
Classification
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Calprotectin IVD, calibrator
BÜHLMANN fCAL® turbo Calibrator Kit by Bühlmann Laboratories AG — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Calprotectin IVD, calibrator.
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Bühlmann Laboratories AG
Sources (1)
- FDA UDI 8582d889-27fa-47a6-a7f5-b6cf98f2586e 35 fields · synced Jun 6, 2026