| Primary Device ID | 06438147371815 |
| NIH Device Record Key | 96b25480-b771-40e0-9abf-3c3ce17977b9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Qsight 210 MD Screening System |
| Version Model Number | 2040-0010 |
| Catalog Number | 2040-0010 |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06438147371815 [Primary] |
| DOP | Mass Spectrometer, Clinical Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-06 |
| Device Publish Date | 2023-03-29 |
| 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 |
| 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 |