| Primary Device ID | 10888234100669 |
| NIH Device Record Key | 3c3d867f-87bc-413e-9c80-b7ba53d7df62 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Filled Vial, HEA 1.2 PCR Mix |
| Version Model Number | 800-00194 |
| Catalog Number | 800-00194 |
| Company DUNS | 949103725 |
| Company Name | BIOARRAY SOLUTIONS LTD |
| 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 | 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 -80 Degrees Celsius and -20 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888234100669 [Primary] |
| PEP | Molecular Erythrocyte Typing Test |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-24 |
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| 10888234100645 - Filled Vial, eMAPTM Elongation Mix | 2018-07-06 |
| 10888234100669 - Filled Vial, HEA 1.2 PCR Mix | 2018-07-06 |
| 10888234100669 - Filled Vial, HEA 1.2 PCR Mix | 2018-07-06 |
| 10888234100683 - Filled Vial, Lambda Exonuclease | 2018-07-06 |
| 10888234100836 - Filled Vial,Negative Control 1mL | 2018-07-06 |
| 10888234100928 - Filled Vial,HotStarTaq DNA Polymerase | 2018-07-06 |
| 10888234102205 - BioArray Assay Imaging SystemTM (AIS) 400C | 2018-07-06 |