| Primary Device ID | 00847627039781 |
| NIH Device Record Key | 29b79fff-06dd-4252-9590-fa143a912007 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeoPATH Pro Universal Negative Control Serum |
| Version Model Number | NPRI10028T40 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847627039781 [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 | 2025-03-28 |
| Device Publish Date | 2025-03-20 |
| 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 |