| Primary Device ID | 10190302000437 |
| NIH Device Record Key | 4b1032ff-df6b-41df-bfe9-610c3875c0f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fast 96-Well Region of Interest (ROI) and Background Plates |
| Version Model Number | 4432638 |
| 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 | false |
| Expiration Date | true |
| 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 | 10190302000437 [Primary] |
| OOI | real time Nucleic acid amplification system |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-06-18 |
| Device Publish Date | 2016-08-01 |
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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 |