| Primary Device ID | EBUHBKCALRSET0 |
| NIH Device Record Key | b5a0a8a0-52bd-4b22-af2d-be1678c15f01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BÜHLMANN fCAL® turbo Reagent Kit |
| Version Model Number | B-KCAL-RSET |
| Company DUNS | 481261006 |
| Company Name | Bühlmann Laboratories AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com | |
| Phone | (844) 300-9799 |
| info@buhlmannlabs.com |
| 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 | EBUHBKCALRSET0 [Primary] |
| NXO | Calprotectin, Fecal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-11 |
| Device Publish Date | 2019-11-01 |
| EBUHBKCALRSET0 | Reagent kit for quantitative PETIA assay for the determination of calprotectin (MRP8/14) in huma |
| EBUHBKPELARSET0 | B-KCAL-RSET |
| EBUHBKCALRSETUS0 | B-KCAL-RSET-US |