Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000191380

FEI Number

1000191380

Entity Name

BUHLMANN LABORATORIES AG

City/State/Country

SCHONENBUCH/BASEL Basel-Landschaft, CH

Establishment Address

BASELSTRASSE 55, SCHONENBUCH/BASEL Basel-Landschaft CH-4124, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BUHLMANN LABORATORIES AG (Owner Number: 9023594)

Owner / Operator Contact Address

BASELSTRASSEE 55, --, SCHONENBUCH/BASEL, CH-BL CH-4124, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BUHLMANN fCAL® ELISA (fecal calprotectin) CAST® Wash Buffer Basophil CAST® Lysing Reagent Basophil Buhlmann CIC-C1q EIA Simple Sampler Stool Collection Set CALEX® Cap Quantum Blue® Reader Buhlmann ACE Kinetic Assay BUHLMANN fPELA® turbo (fecal pancreatic elastase turbidimetric assay) Extraction Kit BUHLMANN fCAL® turbo (fecal calprotectin turbidimetric assay) CAST® Stimulation Buffer Basophil

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NXO	Calprotectin, Fecal	Immunology	Class 2	866.5180	2018-10-23
IGC	Formalin-Saline	Pathology	Class 1	864.4010	2025-02-26
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	2025-02-26
DAK	Complement C1q, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2007-12-07
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2016-07-27
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2021-01-12
KQN	Radioassay, Angiotensin Converting Enzyme	Clinical Chemistry	Class 2	862.1090	2007-12-07
JNN	P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin	Clinical Chemistry	Class 1	862.1725	2020-06-22
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2020-04-15
NXO	Calprotectin, Fecal	Immunology	Class 2	866.5180	2019-07-05
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2025-02-26

Official Correspondent

No official correspondent registered.

US Agent Details

Collin Shaw Business: CEO Email: cms@buhlmannlabs.com Phone: (603) 7320674

Related Public Records

Same Entity

BUHLMANN LABORATORIES AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K760232	Instrumentation Laboratory CO	PRINTER, IL 460	1976-08-26

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9615139	EUROSPITAL S.P.A.	TRIESTE, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000191380. Last updated year: 2026. Please use registration number 1000191380 when referencing this establishment in official correspondence.