| Primary Device ID | 00404847453553 |
| NIH Device Record Key | b1d70c51-d791-4119-80f9-f0d8e156a508 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FSH |
| Version Model Number | HYE-5355 |
| Catalog Number | HYE-5355 |
| Company DUNS | 317134468 |
| Company Name | DRG Instruments Gesellschaft mit beschränkter Haftung |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com |
| 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 |
| 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 | 00404847453553 [Primary] |
| NGA | TEST, FOLLICLE STIMULATING HORMONE (FSH), OVER THE COUNTER |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-15 |
| Device Publish Date | 2021-06-07 |
| 00404847453553 | The DRG:HYBRId-XL FSH is an enzyme immunoassay for the quantitative in vitro diagnostic measurem |
| 04048474053555 | The DRG:HYBRId-XL FSH is an enzyme immunoassay for the quantitative in vitro diagnostic measurem |