| Primary Device ID | EBUHKKACK20 |
| NIH Device Record Key | 66666c88-5853-4ad2-82be-c39457b5d780 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BÜHLMANN ACE Kinetic |
| Version Model Number | KK-ACK2 |
| Catalog Number | KK-ACK2 |
| Company DUNS | 481261006 |
| Company Name | Bühlmann Laboratories AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EBUHKKACK20 [Primary] |
| KQN | Radioassay, Angiotensin Converting Enzyme |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-07 |
| Device Publish Date | 2025-06-27 |
| EBUHKKACK20 - BÜHLMANN ACE Kinetic | 2025-07-07The 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. |
| EBUHKKACK20 - BÜHLMANN ACE Kinetic | 2025-07-07 The BÜHLMANN ACE kinetic assay is intended for the direct and quantitative in vitro diagnostic determination of angiotensin con |
| EBUHBCCRLYR20 - CAST® Lysing Reagent Basophil | 2025-03-12 CAST® Lysing Reagent Basophil (B-CCR-LYR20) is a red cell lysing reagent designed for selective lysis of erythrocytes in basoph |
| EBUHBCCRSR20 - CAST® Staining Reagent Basophil | 2025-03-12 CAST® Staining Reagent Basophil (B-CCR-SR20) is an analyte-specific reagent (ASR) containing fluorescently labeled anti-CCR3 an |
| EBUHBCCRSTB5 - CAST® Stimulation Buffer Basophil | 2025-03-12 CAST® Stimulation Buffer Basophil (B-CCR-STB5) is a blood cell diluent, optimized to support basophil activation in basophil ac |
| EBUHBCCRSTCON10 - CAST® Stimulation Control Basophil | 2025-03-12 CAST® Stimulation Control Basophil (B-CCR-STCON10) is an analyte-specific reagent (ASR) containing a monoclonal anti-FceRI anti |
| EBUHBCCRWB10 - CAST® Wash Buffer Basophil | 2025-03-12 CAST® Wash Buffer Basophil (B-CCR-WB10) is a formalin-saline solution used to wash, fixate and reconstitute basophils in basoph |
| EBUHBCALSAMPLER250 - Simple Sampler Stool Collection Set | 2023-07-04 |
| EBUHBKCALRSETUS0 - BÜHLMANN fCAL® turbo Reagent Kit | 2023-05-10 |