FDA Registration
Active
🇨🇭 Switzerland
BUHLMANN LABORATORIES AG
Reg #: 1000191380
·
FEI: 1000191380
·
Expires 2026
Products
11
Proprietary Names
16
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- BUHLMANN LABORATORIES AG
- Registration Number
- 1000191380
- FEI Number
- 1000191380
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- BASELSTRASSE 55
- City
- SCHONENBUCH/BASEL Basel-Landschaft
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K181012
Owner / Operator
- Firm Name
- BUHLMANN LABORATORIES AG
- Operator Number
- 9023594
- Address
- BASELSTRASSEE 55, --
- City
- SCHONENBUCH/BASEL
- State
- Basel-Landschaft
- Postal Code
- CH-4124
- Country
- CH
US Agent
- Business Name
- CEO
- Contact Name
- Collin Shaw
- Address
- 105 State Route 101A, Suite 1
- City
- Amherst
- State
- NH
- ZIP
- 03031
- Country
- US
- [email protected]
- Phone
- 603 7320674 ext. 212
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calprotectin, Fecal | NXO | Class 2 | Immunology | No | 2018-10-23 |
| Formalin-Saline | IGC | Class 1 | Pathology | No | 2025-02-26 |
| Products, Red-Cell Lysing Products | GGK | Class 1 | Hematology | No | 2025-02-26 |
| Complement C1q, Antigen, Antiserum, Control | DAK | Class 2 | Immunology | No | 2007-12-07 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2016-07-27 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2021-01-12 |
| Radioassay, Angiotensin Converting Enzyme | KQN | Class 2 | Clinical Chemistry | No | 2007-12-07 |
| P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin | JNN | Class 1 | Clinical Chemistry | No | 2020-06-22 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2020-04-15 |
| Diluent, Blood Cell | GIF | Class 1 | Hematology | No | 2025-02-26 |
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 2025-02-26 |
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
CAST® Staining Reagent Basophil
CAST® Stimulation Control Basophil
BUHLMANN fCAL® turbo (fecal calprotectin turbidimetric assay), CALEX® Cap (stool preparation device)
fCAL turbo, fCAL Calibrator Set, fCAL Control Set (fecal calprotectin turbidimetric assay), CALEX® Cap
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device