| Primary Device ID | 04719872782278 |
| NIH Device Record Key | 055b19d9-2d78-4feb-8cbc-129fd8e2efe7 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | PG-0602A-024 |
| Company DUNS | 658637223 |
| Company Name | PHARMIGENE, Inc. |
| 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 | true |
| 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 | +886227985885 |
| service@pharmigene.com | |
| Phone | +886227985885 |
| service@pharmigene.com | |
| Phone | +886227985885 |
| service@pharmigene.com | |
| Phone | +886227985885 |
| service@pharmigene.com | |
| Phone | +886227985885 |
| service@pharmigene.com | |
| Phone | +886227985885 |
| service@pharmigene.com | |
| Phone | +886227985885 |
| service@pharmigene.com | |
| Phone | +886227985885 |
| service@pharmigene.com | |
| Phone | +886227985885 |
| service@pharmigene.com | |
| Phone | +886227985885 |
| service@pharmigene.com | |
| Phone | +886227985885 |
| service@pharmigene.com | |
| Phone | +886227985885 |
| service@pharmigene.com | |
| Phone | +886227985885 |
| service@pharmigene.com | |
| Phone | +886227985885 |
| service@pharmigene.com | |
| Phone | +886227985885 |
| service@pharmigene.com | |
| Phone | +886227985885 |
| service@pharmigene.com |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04719872782278 [Primary] |
| MVU | Reagents, Specific, Analyte |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-22 |
| Device Publish Date | 2023-06-14 |
| 04719872780014 - NA | 2023-06-22 The PGIC01 Detection Reagent is used for amplification of an internal control gene. |
| 04719872780205 - NA | 2023-06-22 The PG1502 Detection Reagent is used for amplification of the HLA-B*1502 allele. |
| 04719872780441 - NA | 2023-06-22 The PG5801 Detection Reagent is used for amplification of the HLA-B*5801 allele. |
| 04719872780618 - NA | 2023-06-22 The PG5701 Detection Reagent is used for amplification of the HLA-B*5701 allele. |
| 04719872780717 - NA | 2023-06-22 The PG3101 Detection Reagent is used for amplification of the HLA-A*3101 allele. |
| 04719872780878 - NA | 2023-06-22 The PG27 Detection Reagent is used for amplification of the HLA-B*27 allele. |
| 04719872781653 - NA | 2023-06-22 The PG1639 Detection Reagent is used for detection of the VKORC1-1639 (G>A) SNP. |
| 04719872781691 - NA | 2023-06-22 The PG1075 Detection Reagent is used for detection of the CYP2C9*3 (c.1075 A>C) SNP. |