| Primary Device ID | 06438147356829 |
| NIH Device Record Key | dd8880c7-97fd-4fca-9cd5-ff04b7320cf7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeoBase 2 Succinylacetone Assay Solution |
| Version Model Number | 3046-0010 |
| Catalog Number | 3046-0010 |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06438147356829 [Primary] |
| NQL | System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-04-30 |
| Device Publish Date | 2019-02-25 |
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| 06438147386918 - Buffer M | 2023-04-25 |
| 06438147386956 - DBS Controls M2 | 2023-04-25 The DBS Controls M2 is intended for use as an external control material to evaluate the performance of lysosomal enzyme activity |
| 06438147386963 - Iduronate 2-sulfatase S&IS | 2023-04-25 Vials contain Iduronate 2-sulfatase -substrate and Iduronate 2-sulfatase -internal standard, which can be used to measure the Id |
| 06438147371815 - Qsight 210 MD Screening System | 2023-04-06 |
| 06438147384709 - Qsight 225 MD Screening System | 2023-04-06 |
| 06438147373901 - Eonis Analysis software | 2022-12-12 The Eonis Analysis Software is intended for in vitro diagnostic use for analysis of the real time PCR data generated usingthe Eo |
| 06438147377718 - Eonis DNA Extraction kit | 2022-12-08 The Eonis DNA Extraction kit is a device intended for isolation and purification of DNA in newborn blood specimens dried on filt |