INFINITI® High Throughput System (HTS) ACE ANALYZER 10-0030-99
GUDID 00850009370013
Instrumentation For Clinical Multiplex Test Systems
AUTOGENOMICS, INC
Microarray analyser IVD, semi-automated| Primary Device ID | 00850009370013 |
| NIH Device Record Key | 1c61b5ea-4c27-4f82-b7e6-e0392445606b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INFINITI® High Throughput System (HTS) ACE ANALYZER |
| Version Model Number | 10-0030-99 |
| Catalog Number | 10-0030-99 |
| 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
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850009370013 [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
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| 30850009370243 - AvertD™ (96) PE Mix | 2024-11-26 The PE Mix Reagent Module acts as a communication link with up to four reservoirs that house the test reagents as the Primer Ext |
| 30850009370250 - AvertD™ (96) AMP Mix | 2024-11-26 The Amplification Mix provides the reagent for the PCR amplification of the DNA sample as part of AvertD™, a prescription, qua |
| 10850009370195 - AvertD™ Amplification Mix | 2024-06-10 The Amplification Mix provides the reagent for the PCR amplification of the DNA sample as part of AvertD™, a prescription, qua |
| 10850009370201 - AvertD™ Intellipac Reagent Module | 2024-06-10 The Intellipac Reagent Module acts as a communication link with up to four reservoirs that house the test reagents as the Primer |
| 10850009370218 - AvertD™ BioFilmChip Microarray Magazine | 2024-06-10 The BioFilmChip Microarray consists of a polyester film coated with proprietary multi-layer components designed for DNA analysis |
| 10850009370225 - AvertD™ Buccal Sample Collection Kit | 2024-06-10 Buccal Sample Collection Kit for use with AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 |
| 00850009370006 - INFINITI® PLUS ANALYZER | 2019-10-31 Instrumentation For Clinical Multiplex Test Systems |
Trademark Results [INFINITI]
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