| Primary Device ID | 06438147321209 |
| NIH Device Record Key | c5c1adbb-8b21-40ed-9d6c-0e19d2d087f7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GSP Neonatal 17α-OH-progesterone kit |
| Version Model Number | 3305-001U |
| Catalog Number | 3305-001U |
| 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 | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06438147321209 [Primary] |
| JLX | Radioimmunoassay, 17-Hydroxyprogesterone |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-12-17 |
| Device Publish Date | 2018-11-16 |
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