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BUHLMANN LABORATORIES AG

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10001913801000191380BUHLMANN LABORATORIES AG1N2026-01-01BASELSTRASSE 55 SCHONENBUCH/BASEL Basel-Landschaft CH CH-4124

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
EBUHBCCRWB10CAST® Wash Buffer Basophil - CAST® Wash Buffer Basophil (B-CCR-WB10) is a formalin-saline solution used to wash, fixate and reconstitute basophils in basophil activation assays, ensuring proper sample preparation for flow cytometry analysis.(844)300-9799info@buhlmannlabs.com
EBUHKKACK21ACE Kinetic Kit - 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.(844) 300-9799info@buhlmannlabs.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
771491840249068K954299BUHLMANN ANGIOSTENSIN II RIACIB1995-10-19
771491308551101K942497ANGIOTENSIN CONVERTING ENZYME REAKQN1994-11-15
771491552435791K913091BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAYKQN1991-08-26
771491125156869K232057BÜHLMANN fCAL® turbo and CALEX® CapNXO2024-02-06
771491201546919K191718Buhlmann fCAL turbo and CALEX CapNXO2019-09-24
771491524584027K190784BUHLMANN fCAL turboNXO2019-06-25
771491801399539K181012BUHLMANN fCAL ELISANXO2018-06-04
771491115445174K081875GENTIAN CYSTATIN C IMMUNOASSAYNDY2008-08-20
771491160861825K012576CIC-C1Q EIADAK2002-01-29
771491254765391
771491011073624
771491201602201
771491356724675
771491442249021
771491602999033
771491824597772
771491874020721
771491959744917

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NXO42024-02-06
KQN21994-11-15
NDY12008-08-20
DAK12002-01-29
CIB11995-10-19

PMN#

GUDID#

BÜHLMANN fPELA® turbo Reagent Kit - The BÜHLMANN fPELA® turbo is an in vitro diagnostic test for the quantitative determination of pancreatic elastase in human fecal extracts. The results can be used as an aid to determination of exocrine pancreatic insufficiency in patients suffering from conditions such as chronic pancreatitis in conjunction with other laboratory and clinical findings. The BÜHLMANN fPELA® turbo assay is intended to be run on clinical chemistry analyzers.

Bühlmann Laboratories AG

2020-06-22