| Primary Device ID | 00847627036957 | 
| NIH Device Record Key | ed4b3241-cf18-4170-b06a-d543bff7dd0c | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | SOX10 (M) | 
| Version Model Number | NPAI3099T40 | 
| 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 | 
| 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 | 00847627036957 [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 | 2025-06-30 | 
| Device Publish Date | 2025-06-20 | 
| 00847627025760 | ALI3099G7 | 
| 00847627025104 | OPAI3099T60 | 
| 00847627014177 | AVI3099H | 
| 00847627008930 | IPI3099G10 | 
| 00847627004970 | AVI3099G | 
| 00847627004147 | API3099H | 
| 00847627004130 | API3099AA | 
| 00847627002914 | ACI3099C | 
| 00847627002907 | ACI3099A | 
| 00847627036582 | API3099G25 | 
| 00847627036964 | NPAI3099T80 | 
| 00847627036957 | NPAI3099T40 |