buhlmannlabs.comBuhlmann FCAL Turbo And CALEX Cap
BUHLMANN Laboratories AG
BUHLMANN LABORATORIES AG
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1000191380 | 1000191380 | BUHLMANN LABORATORIES AG | 1 | N | 2026-01-01 | BASELSTRASSE 55 SCHONENBUCH/BASEL Basel-Landschaft CH CH-4124 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| EBUHBCCRWB10 | CAST® 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)300-9799 | info@buhlmannlabs.com |
| EBUHKKACK21 | ACE 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) 300-9799 | info@buhlmannlabs.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 77149 | 1840249068 | K954299 | BUHLMANN ANGIOSTENSIN II RIA | CIB | 1995-10-19 |
| 77149 | 1308551101 | K942497 | ANGIOTENSIN CONVERTING ENZYME REA | KQN | 1994-11-15 |
| 77149 | 1552435791 | K913091 | BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY | KQN | 1991-08-26 |
| 77149 | 1125156869 | K232057 | BÜHLMANN fCAL® turbo and CALEX® Cap | NXO | 2024-02-06 |
| 77149 | 1201546919 | K191718 | Buhlmann fCAL turbo and CALEX Cap | NXO | 2019-09-24 |
| 77149 | 1524584027 | K190784 | BUHLMANN fCAL turbo | NXO | 2019-06-25 |
| 77149 | 1801399539 | K181012 | BUHLMANN fCAL ELISA | NXO | 2018-06-04 |
| 77149 | 1115445174 | K081875 | GENTIAN CYSTATIN C IMMUNOASSAY | NDY | 2008-08-20 |
| 77149 | 1160861825 | K012576 | CIC-C1Q EIA | DAK | 2002-01-29 |
| 77149 | 1254765391 | ||||
| 77149 | 1011073624 | ||||
| 77149 | 1201602201 | ||||
| 77149 | 1356724675 | ||||
| 77149 | 1442249021 | ||||
| 77149 | 1602999033 | ||||
| 77149 | 1824597772 | ||||
| 77149 | 1874020721 | ||||
| 77149 | 1959744917 |
Product Codes Associated With Registrations#
PMN#
BUHLMANN FCAL Turbo
BUHLMANN Laboratories AG
BUHLMANN FCAL ELISA
BUHLMANN Laboratories AG
BUHLMANN ANGIOSTENSIN II RIA
BUHLMANN LABORATORIES AG
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.
2020-06-22
BÜHLMANN ACE Kinetic - The BÜHLMANN ACE kinetic assay is intended for the direct and quantitative in vitro diagnostic determination of angiotensin converting enzyme (ACE) activity in serum samples by enzymatic assay.
2025-06-27
ACE 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.
2016-09-01
CAST® Lysing Reagent Basophil - CAST® Lysing Reagent Basophil (B-CCR-LYR20) is a red cell lysing reagent designed for selective lysis of erythrocytes in basophil activation assays, ensuring optimal basophil analysis by flow cytometry
2025-03-04
CAST® Staining Reagent Basophil - CAST® Staining Reagent Basophil (B-CCR-SR20) is an analyte-specific reagent (ASR) containing fluorescently labeled anti-CCR3 and anti-CD63 monoclonal antibodies for basophil identification and activation status assessment in basophil activation assays.
2025-03-04
CAST® Stimulation Buffer Basophil - CAST® Stimulation Buffer Basophil (B-CCR-STB5) is a blood cell diluent, optimized to support basophil activation in basophil activation assays by providing a controlled stimulation environment.
2025-03-04
CAST® Stimulation Control Basophil - CAST® Stimulation Control Basophil (B-CCR-STCON10) is an analyte-specific reagent (ASR) containing a monoclonal anti-FceRI antibody to activate basophils via the IgE-mediated pathway in basophil activation assays.
2025-03-04
CAST® 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.
2025-03-04
BÜHLMANN fCAL® turbo Reagent Kit - B-KCAL-RSET-US
2023-05-02
fCAL turbo - 08910367190
2022-06-13
Simple Sampler Stool Collection Set - B-CAL-SAMPLER25
2023-06-26
BÜHLMANN fPELA® turbo Control Kit - B-KPELA-CONSET
2020-06-22
BÜHLMANN fPELA® turbo Calibrator Kit - B-KPELA-CASET
2020-06-22
fCAL turbo - 08910332190
2020-05-27
fCAL Calibrator Set - 08910499190
2020-05-27
BÜHLMANN fCAL® ELISA - Quantitative ELISA assay for the determination of calprotectin (MRP8/14) in human stool specimens
2019-11-06
BÜHLMANN fCAL® ELISA - Quantitative ELISA assay for the determination of calprotectin (MRP8/14) in human stool specimens
2019-11-06
BÜHLMANN fCAL® turbo Calibrator Kit - Calibrator kit for quantitative PETIA assay for the determination of calprotectin (MRP8/14) in human stool specimens
2019-11-01
BÜHLMANN fCAL® turbo Reagent Kit - Reagent kit for quantitative PETIA assay for the determination of calprotectin (MRP8/14) in human stool specimens
2019-11-01
Quantum Blue® Reader - BI-POCTR-ABS
2021-01-12
CALEX Cap - 08910987001
2020-05-27
CALEX® Cap, 200 pieces - B-CALEX-C200
2020-01-30
CALEX® Cap, 50 pieces - B-CALEX-C50
2020-01-30
CALEX® Cap, 500 pieces - B-CALEX-C500
2020-01-30
Extraction Kit - 12 buffer containers - B-CAL-EX12
2020-04-15
Extraction kit - 3 buffer containers - B-CAL-EX3
2020-04-15
fCAL Control Set - 08910502190
2020-05-27
BÜHLMANN fCAL® turbo Control Kit - Control kit for quantitative PETIA assay for the determination of calprotectin (MRP8/14) in human stool specimens
2019-11-01
CIC-C1q ELISA Kit - 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.
2016-09-01
ACE Kinetik 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.
2016-09-01
ACE 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.
2016-09-01
ACE 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.
2016-09-01
Angiotensin II RIA - The BÜHLMANN Angiotensin II is a double antibody radioimmunoassay designed for the quantitative in vitro diagnostic determination of immunoreactive Angiotensin II in extracted EDTA plasma.
2016-09-01