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BÜHLMANN fCAL® ELISA

FDA UDI

Class II (US FDA UDI)

by Bühlmann Laboratories AG

Identity

Trade Name
BÜHLMANN fCAL® ELISA FDA UDI
Generic Name
Calprotectin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Quantitative ELISA assay for the determination of calprotectin (MRP8/14) in human stool specimens FDA UDI
Model / Reference
EK-CAL FDA UDI
Description
Quantitative ELISA assay for the determination of calprotectin (MRP8/14) in human stool specimens FDA UDI

Identifiers

Primary DI / UDI-DI
EBUHBEKCAL0 FDA UDI
FDA Product Code
NXO FDA UDI
GMDN Term
Calprotectin IVD, kit, enzyme immunoassay (EIA) 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, kit, enzyme immunoassay (EIA)

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

Similar devices

Also classified as Calprotectin IVD, kit, enzyme immunoassay (EIA).

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 35529fec-8c64-4ddd-9b7f-182784fdd321 35 fields · synced May 30, 2026