| Primary Device ID | 00850646007334 | 
| NIH Device Record Key | 656c6046-dac1-44e1-981b-6f44cd331577 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | AEC Substrate Pack | 
| Version Model Number | HK129-5KE | 
| Catalog Number | HK129-5KE | 
| Company DUNS | 042697045 | 
| Company Name | BIOGENEX LABORATORIES | 
| 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 | 
| Phone | +1 (800) 421-4149 | 
| support@biogenex.com | |
| Phone | +1 (800) 421-4149 | 
| support@biogenex.com | |
| Phone | +1 (800) 421-4149 | 
| support@biogenex.com | |
| Phone | +1 (800) 421-4149 | 
| support@biogenex.com | |
| Phone | +1 (800) 421-4149 | 
| support@biogenex.com | |
| Phone | +1 (800) 421-4149 | 
| support@biogenex.com | |
| Phone | +1 (800) 421-4149 | 
| support@biogenex.com | |
| Phone | +1 (800) 421-4149 | 
| support@biogenex.com | |
| Phone | +1 (800) 421-4149 | 
| support@biogenex.com | |
| Phone | +1 (800) 421-4149 | 
| support@biogenex.com | |
| Phone | +1 (800) 421-4149 | 
| support@biogenex.com | |
| Phone | +1 (800) 421-4149 | 
| support@biogenex.com | |
| Phone | +1 (800) 421-4149 | 
| support@biogenex.com | |
| Phone | +1 (800) 421-4149 | 
| support@biogenex.com | |
| Phone | +1 (800) 421-4149 | 
| support@biogenex.com | |
| Phone | +1 (800) 421-4149 | 
| support@biogenex.com | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at 2-8°C | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at 2-8°C | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at 2-8°C | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at 2-8°C | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at 2-8°C | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at 2-8°C | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at 2-8°C | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at 2-8°C | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at 2-8°C | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at 2-8°C | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at 2-8°C | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at 2-8°C | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at 2-8°C | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at 2-8°C | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at 2-8°C | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at 2-8°C | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00850646007334 [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 | 2023-05-29 | 
| Device Publish Date | 2023-05-19 | 
| 00810119675187 - ANTI-PAX5 | 2023-05-29 | 
| 00810119675972 - ANTI-HLA-DR | 2023-05-29 | 
| 00810119676061 - Anti- c-Myc | 2023-05-29 | 
| 00810119676221 - LIQUID DAB, CHROMOGEN | 2023-05-29 | 
| 00810119676252 - H.PYLORI | 2023-05-29 | 
| 00850646007327 - AEC (Aminoethylcarbazole) | 2023-05-29 | 
| 00850646007334 - AEC Substrate Pack | 2023-05-29 | 
| 00850646007334 - AEC Substrate Pack | 2023-05-29 | 
| 00850646007341 - Diluent | 2023-05-29 |