| Primary Device ID | 00847627038395 | 
| NIH Device Record Key | f058a706-0d2d-4a0b-9a90-2bdf73c0b2bd | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Smooth Muscle Actin (SMA) | 
| Version Model Number | NPAI001T80 | 
| 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 | 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00847627038395 [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 | 
| 00847627025401 | OPAI001T60 | 
| 00847627010551 | PM001H | 
| 00847627008404 | IP001G10 | 
| 00847627038395 | NPAI001T80 | 
| 00847627038388 | NPAI001T40 |