| Primary Device ID | 00847627014443 |
| NIH Device Record Key | 90f289f6-b470-46ba-9d49-76f224b18181 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rubens Eosin-Phloxine |
| Version Model Number | HTEP-GL |
| 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 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847627014443 [Primary] |
| HYB | Eosin Y |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-15 |
| Device Publish Date | 2022-12-07 |
| 00847627036735 - CD68 [KP1] | 2025-03-28 |
| 00847627036773 - Leukocyte Common Antigen (LCA) Cocktail | 2025-03-28 |
| 00847627036797 - Ki-67 [MIB-1] | 2025-03-28 |
| 00847627036810 - Ki-67 [MIB-1] | 2025-03-28 |
| 00847627036834 - S100 Protein [4C4.9] (M) | 2025-03-28 |
| 00847627036841 - S100 Protein [4C4.9] (M) | 2025-03-28 |
| 00847627036919 - p63 | 2025-03-28 |
| 00847627036926 - p63 | 2025-03-28 |