| Primary Device ID | 06438147001262 |
| NIH Device Record Key | 0aba8d0e-8473-4cc6-9900-16cf266f49a7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Neonatal GALT kit |
| Version Model Number | NG-1100 |
| Catalog Number | NG-1100 |
| 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 | 06438147001262 [Primary] |
| KQP | Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase |
| 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 | 2016-02-02 |
| 06438147001279 | For the quantitative determination of GALT (galactose-1-phosphate uridyl transferase) in dried b |
| 06438147001262 | For the quantitative determination of GALT (galactose-1-phosphate uridyl transferase) in dried b |