INFINITI® High Throughput System (HTS) INCUBATOR 10-0070-99
GUDID 00850009370037
Instrumentation For Clinical Multiplex Test Systems
AUTOGENOMICS, INC
Microarray analyser IVD, semi-automated Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD Microarray analyser IVD| Primary Device ID | 00850009370037 |
| NIH Device Record Key | 30d7349a-6f87-4027-b76b-cda3a8ed2c48 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INFINITI® High Throughput System (HTS) INCUBATOR |
| Version Model Number | 10-0070-99 |
| Catalog Number | 10-0070-99 |
| Company DUNS | 027914535 |
| Company Name | AUTOGENOMICS, INC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850009370037 [Primary] |
FDA Product Code
| NSU | Instrumentation for clinical multiplex test systems |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-31 |
| Device Publish Date | 2019-10-23 |
Devices Manufactured by AUTOGENOMICS, INC
| 00850009370006 - INFINITI® PLUS ANALYZER | 2019-10-31 Instrumentation For Clinical Multiplex Test Systems |
| 00850009370013 - INFINITI® High Throughput System (HTS) ACE ANALYZER | 2019-10-31 Instrumentation For Clinical Multiplex Test Systems |
| 00850009370020 - INFINITI® High Throughput System (HTS) PROCESSOR | 2019-10-31 Instrumentation For Clinical Multiplex Test Systems |
| 00850009370037 - INFINITI® High Throughput System (HTS) INCUBATOR | 2019-10-31Instrumentation For Clinical Multiplex Test Systems |
| 00850009370037 - INFINITI® High Throughput System (HTS) INCUBATOR | 2019-10-31 Instrumentation For Clinical Multiplex Test Systems |
| 00850009370044 - INFINITI® Factor II BioFilmChip® Microarray Magazine | 2019-10-31 Genotyping system for the detection of Factor II (Prothrombin) G20210A mutations. |
| 00850009370051 - INFINITI® Factor II Intellipac® Reagent Module | 2019-10-31 Genotyping system for the detection of Factor II (Prothrombin) G20210A mutation |
| 00850009370068 - INFINITI® Factor II Amplification Mix | 2019-10-31 Genotyping system for the detection of Factor II (Prothrombin) G20210A mutations. |
| 00850009370075 - INFINITI® Factor V Leiden BioFilmChip® Microarray Magazine | 2019-10-31 Genotyping system for the detection of the Factor V Leiden G1691A mutation |
Trademark Results [INFINITI]
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