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BÜHLMANN fCAL® turbo Reagent Kit

FDA UDI

Class II (US FDA UDI)

by Bühlmann Laboratories AG

Identity

Trade Name
BÜHLMANN fCAL® turbo Reagent Kit FDA UDI
Generic Name
Calprotectin IVD, reagent FDA UDI
Device Name
Reagent kit for quantitative PETIA assay for the determination of calprotectin (MRP8/14) in human stool specimens FDA UDI
Model / Reference
B-KCAL-RSET FDA UDI
Description
Reagent kit for quantitative PETIA assay for the determination of calprotectin (MRP8/14) in human stool specimens FDA UDI

Identifiers

Primary DI / UDI-DI
EBUHBKCALRSET0 FDA UDI
FDA Product Code
NXO FDA UDI
GMDN Term
Calprotectin IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5180 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

Yes

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: Calprotectin IVD, reagent

BÜHLMANN fCAL® turbo Reagent Kit by Bühlmann Laboratories AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Calprotectin IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bühlmann Laboratories AG

Sources (1)

  • FDA UDI b5a0a8a0-52bd-4b22-af2d-be1678c15f01 35 fields · synced May 30, 2026