Bühlmann Laboratories AG

Address:BASELSTRASSE 55,SCHONENBUCH/BASEL Basel-Landschaft,CH

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Calprotectin, Fecal (NXO) (2) Complement C1q, Antigen, Antiserum, Control (DAK) (1) Radioassay, Angiotensin Converting Enzyme (KQN) (1)

Premarket Exempt

No Yes

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BÜHLMANN fCAL® ELISA - EBUHBEKCAL0 Catalog Number :

Device Description : Quantitative ELISA assay for the determination of calprotectin (MRP8/14) in huma Quantitative ELISA assay for the determination of calprotectin (MRP8/14) in human stool specimens

Device Class : 2

Duns Number: 481261006

Premarket Exempt : No

Product Code : NXO

Prescription Use : Yes

Device Count : 1

BÜHLMANN fCAL® ELISA - EBUHBEKCAL20 Catalog Number :

Device Description : Quantitative ELISA assay for the determination of calprotectin (MRP8/14) in huma Quantitative ELISA assay for the determination of calprotectin (MRP8/14) in human stool specimens

Device Class :

Duns Number: 481261006

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Quantum Blue® Reader - EBUHBIPOCTRABS0 Catalog Number :

Device Class :

Duns Number: 481261006

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

BÜHLMANN fCAL® turbo Calibrator Kit - EBUHBKCALCASET0 Catalog Number :

Device Description : Calibrator kit for quantitative PETIA assay for the determination of calprotecti Calibrator kit for quantitative PETIA assay for the determination of calprotectin (MRP8/14) in human stool specimens

Device Class :

Duns Number: 481261006

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

BÜHLMANN fCAL® turbo Control Kit - EBUHBKCALCONSET0 Catalog Number :

Device Description : Control kit for quantitative PETIA assay for the determination of calprotectin ( Control kit for quantitative PETIA assay for the determination of calprotectin (MRP8/14) in human stool specimens

Device Class :

Duns Number: 481261006

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

BÜHLMANN fCAL® turbo Reagent Kit - EBUHBKCALRSET0 Catalog Number :

Device Description : Reagent kit for quantitative PETIA assay for the determination of calprotectin ( Reagent kit for quantitative PETIA assay for the determination of calprotectin (MRP8/14) in human stool specimens

Device Class : 2

Duns Number: 481261006

Premarket Exempt : No

Product Code : NXO

Prescription Use : Yes

Device Count : 1

BÜHLMANN fPELA® turbo Control Kit - EBUHBKPELACONSET0 Catalog Number :

Device Class :

Duns Number: 481261006

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

BÜHLMANN fCAL® turbo Reagent Kit - EBUHBKPELARSET0 Catalog Number :

Device Class :

Duns Number: 481261006

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

CIC-C1q ELISA Kit - EBUHEKCIC1 Catalog Number : EK-CIC

Device Description : The BÜHLMANN CIC-C1Q EIA is intended for the quantitative in vitro dia The BÜHLMANN CIC-C1Q EIA is intended for the quantitative in vitro diagnostic determination of circulating immune complexes (CIC) in serum and plasma of patients with various autoimmune and other CIC-related diseases.

Device Class : 2

Duns Number: 481261006

Premarket Exempt : No

Product Code : DAK

Prescription Use : No

Device Count : 1

ACE Kinetik Kit - EBUHKKACK1 Catalog Number : KK-ACK

Device Description : The BÜHLMANN ACE kinetic test is intended for the direct and quantitative in The BÜHLMANN ACE kinetic test is intended for the direct and quantitative in vitro diagnostic determination of angiotensin converting enzyme (ACE) activity in serum by an enzymatic assay.

Device Class : 2

Duns Number: 481261006

Premarket Exempt : No

Product Code : KQN

Prescription Use : No

Device Count : 1

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