| Primary Device ID | 00847627035509 |
| NIH Device Record Key | 61265a7c-875a-43cc-a492-2b50e978c308 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARCHV – Antigen Retrieval Chamber High Voltage (Recertified) |
| Version Model Number | DCARC0003-R |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847627035509 [Primary] |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-10 |
| Device Publish Date | 2024-07-02 |
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| 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 |