| Primary Device ID | 00847627034885 |
| NIH Device Record Key | 8d5c9999-f2d7-4b60-b77f-10698128346b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mouse Amp AP Detection |
| Version Model Number | OPRI6088T60 |
| Company DUNS | 806617825 |
| Company Name | BIOCARE MEDICAL LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | false |
| 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 |
| 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 |
| 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 | 00847627034885 [Primary] |
| PPM | General Purpose Reagent |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-06 |
| Device Publish Date | 2023-06-28 |
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| 00847627040220 - CK5 + p63 | 2025-09-29 |
| 00847627040237 - CK5 + p63 | 2025-09-29 |
| 00847627041258 - CD23 | 2025-09-29 |
| 00847627042941 - CD3 [LN10] | 2025-09-29 |
| 00847627039668 - PAX5 | 2025-09-22 |
| 00847627041678 - Napsin A | 2025-09-15 |
| 00847627040305 - GATA-3 | 2025-09-04 |