| Primary Device ID | 06438147344406 |
| NIH Device Record Key | e81e521d-de46-4249-a095-52db0b96269c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AutoDELFIA Inhibin A kit Level Calibrators |
| Version Model Number | B064-112-P2 |
| Catalog Number | B064-112-P2 |
| Company DUNS | 540156544 |
| Company Name | Wallac Oy |
| 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 | 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 -60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06438147344406 [Primary] |
| NDR | Enzyme Immunoassay, Inhibin-A |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-12-24 |
| Device Publish Date | 2018-11-21 |
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