| Primary Device ID | 06438147295708 |
| NIH Device Record Key | 312a0807-2d2d-4315-8b69-c7f534ac573d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeoBase Succinylacetone Assay Solution |
| Version Model Number | 3042-0020 |
| Catalog Number | 3042-0020 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06438147295708 [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 | 5 |
| Public Version Date | 2018-12-13 |
| Device Publish Date | 2016-02-11 |
| 06438147385478 - RESOLVE Hb FACS Control kit | 2023-04-25 A control for monitoring assay performance in isoelectric focusing techniques used for identifying hemoglobin variants. |
| 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 |