| Primary Device ID | 06438147352401 |
| NIH Device Record Key | 1b822f01-1173-4c9d-a215-7ca22882242e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MSMS Workstation |
| Version Model Number | 5002-0540 |
| Catalog Number | 5002-0540 |
| 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 | true |
| Serial Number | false |
| 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 | 06438147352401 [Primary] |
| JQP | Calculator/Data Processing Module, For 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 | 2018-12-31 |
| Device Publish Date | 2018-11-28 |
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| 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 |