| Primary Device ID | 06438147330911 |
| NIH Device Record Key | 80d84c78-40b7-4491-8a7a-f7e8f3db9327 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GSP Neonatal Biotinidase kit |
| Version Model Number | 3307-001U |
| Catalog Number | 3307-001U |
| Company DUNS | 540156544 |
| Company Name | Wallac Oy |
| 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 | true |
| 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 -30 Degrees Celsius and -16 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06438147330911 [Primary] |
| NAK | System,Test,Biotinidase |
| 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 | 2016-01-12 |
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