| Primary Device ID | 10190302015615 |
| NIH Device Record Key | 4caeacc1-d859-4a58-ab5d-a0c7618db143 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QuantStudio(TM) Dx Software Version 1.0.4 |
| Version Model Number | A48389 |
| Company DUNS | 628548377 |
| Company Name | LIFE TECHNOLOGIES HOLDINGS PTE. LTD. |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| 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 | 10190302015615 [Primary] |
| OOI | real time Nucleic acid amplification system |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-27 |
| Device Publish Date | 2021-04-19 |
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| 10190302019231 - KingFisher™ Apex Dx Purification Instrument | 2023-08-11 |
| 10190302019248 - KingFisher™ Apex Dx 96 PCR Head | 2023-08-11 |
| 10190302019255 - KingFisher™ Apex Dx 96 Combi Head | 2023-08-11 |
| 10190302019262 - KingFisher™ Apex Dx 96 Deep Well Head | 2023-08-11 |
| 10190302019279 - KingFisher™ Apex Dx 24 Combi Head | 2023-08-11 |
| 10190302019408 - Diomni™ Software, Version 4.0.0 | 2023-07-20 |