| Primary Device ID | 00847627042941 | 
| NIH Device Record Key | 91ee1010-a97d-4bc2-8069-e23718547ec6 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | CD3 [LN10] | 
| Version Model Number | NPAI3152T80 | 
| 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 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 | 00847627042941 [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 | 2025-09-29 | 
| Device Publish Date | 2025-09-19 | 
| 00847627004383 | API3152H | 
| 00847627004376 | API3152AA | 
| 00847627003331 | ACI3152C | 
| 00847627003324 | ACI3152A | 
| 00847627037084 | NPAI3152T40 | 
| 00847627042941 | NPAI3152T80 |