| Primary Device ID | 00842365100038 |
| NIH Device Record Key | 9e5eabd5-f061-4a6e-a5cb-02ee2b2a8f83 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TopazTM System |
| Version Model Number | 5050412 |
| Company DUNS | 595281292 |
| Company Name | AB SCIEX (MANUFACTURING) |
| 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 | true |
| 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 | 00842365100038 [Primary] |
| DOP | Mass Spectrometer, Clinical Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-12-21 |
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| 00842365100533 - Citrine Triple Quad™ MS/MS | 2022-10-06 The Citrine system is a liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems intended to identify inorganic or orga |
| 00842365100540 - Citrine QTRAP MS/MS | 2022-10-06 The Citrine system is a liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems intended to identify inorganic or orga |
| 00842365102049 - AB SCIEX Triple Quad™ 4500MD | 2022-10-06 The 4500MD system is a liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems intended to identify inorganic or organ |
| 00842365102063 - AB SCIEX QTRAP® 4500MD | 2022-10-06 The 4500MD system is a liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems intended to identify inorganic or organ |
| 00842365100038 - TopazTM System | 2018-03-29 |
| 00842365100038 - TopazTM System | 2018-03-29 |