| Primary Device ID | 00847627042279 |
| NIH Device Record Key | edd7b8ee-85fb-464e-bf61-3920907eb50d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CK7 |
| Version Model Number | NPAI339T40 |
| Company DUNS | 806617825 |
| Company Name | BIOCARE MEDICAL LLC |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847627042279 [Primary] |
| NJT | Immunohistochemistry Reagents And Kits |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-06 |
| Device Publish Date | 2026-01-29 |
| 00847627012357 | PRM339AA |
| 00847627010797 | PM061AA |
| 00847627008725 | IP339G10 |
| 00847627008169 | CRM339C |
| 00847627008152 | CRM339A |
| 00847627005816 | CM061C |
| 00847627005809 | CM061B |
| 00847627005793 | CM061A |
| 00847627042279 | NPAI339T40 |