| Primary Device ID | EBUHKPELACASET0 |
| NIH Device Record Key | 3fc97ca4-c14a-4b03-8d72-fcbced938579 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BÜHLMANN fPELA® turbo Calibrator Kit |
| Version Model Number | B-KPELA-CASET |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EBUHKPELACASET0 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-30 |
| Device Publish Date | 2020-06-22 |
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| 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 |
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| EBUHBKCALRSETUS0 - BÜHLMANN fCAL® turbo Reagent Kit | 2023-05-10 |
| 04260714340007 - fCAL turbo | 2022-06-21 |