| Primary Device ID | 00847627040190 |
| NIH Device Record Key | a5938fe8-fc74-41f0-81b5-c4180928927c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeoPATH Pro Pepsin |
| Version Model Number | NPRI10030T40 |
| 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 | 00847627040190 [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 |
| 00847627042279 - CK7 | 2026-02-06 |
| 00847627043023 - NeoPATH Pro Rabbit Amp AP Plus Kit | 2026-02-06 |
| 00847627043047 - NeoPATH Pro Universal AP Plus Polymer Kit | 2026-02-06 |
| 00847627043061 - NeoPATH Pro Antigen Retrieval 1 (AR1) | 2026-02-06 |
| 00847627042033 - Desmin | 2026-01-21 |
| 00847627042835 - CD19 | 2026-01-21 |
| 00847627041937 - Myeloperoxidase (P) | 2026-01-14 |
| 00847627042514 - Vimentin | 2026-01-14 |