Primary Device ID | 00850009370044 |
NIH Device Record Key | ea6b0e03-c3db-4766-a5f3-ea3f4daaa65d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | INFINITI® Factor II BioFilmChip® Microarray Magazine |
Version Model Number | 01-1020-01 |
Catalog Number | 01-1020-01 |
Company DUNS | 027914535 |
Company Name | AUTOGENOMICS, INC |
Device Count | 1 |
DM Exempt | true |
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 | true |
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 |
Phone | +1(760)477-2248 |
techsupport@autogenomics.com | |
Phone | +1(760)477-2248 |
techsupport@autogenomics.com | |
Phone | +1(760)477-2248 |
techsupport@autogenomics.com | |
Phone | +1(760)477-2248 |
techsupport@autogenomics.com | |
Phone | +1(760)477-2248 |
techsupport@autogenomics.com | |
Phone | +1(760)477-2248 |
techsupport@autogenomics.com | |
Phone | +1(760)477-2248 |
techsupport@autogenomics.com | |
Phone | +1(760)477-2248 |
techsupport@autogenomics.com | |
Phone | +1(760)477-2248 |
techsupport@autogenomics.com | |
Phone | +1(760)477-2248 |
techsupport@autogenomics.com | |
Phone | +1(760)477-2248 |
techsupport@autogenomics.com | |
Phone | +1(760)477-2248 |
techsupport@autogenomics.com | |
Phone | +1(760)477-2248 |
techsupport@autogenomics.com | |
Phone | +1(760)477-2248 |
techsupport@autogenomics.com | |
Phone | +1(760)477-2248 |
techsupport@autogenomics.com | |
Phone | +1(760)477-2248 |
techsupport@autogenomics.com | |
Phone | +1(760)477-2248 |
techsupport@autogenomics.com | |
Phone | +1(760)477-2248 |
techsupport@autogenomics.com |
Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850009370044 [Primary] |
NPR | TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-10-31 |
Device Publish Date | 2019-10-23 |
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 | 2019-10-31 Instrumentation For Clinical Multiplex Test Systems |
00850009370044 - INFINITI® Factor II BioFilmChip® Microarray Magazine | 2019-10-31Genotyping system for the detection of Factor II (Prothrombin) G20210A mutations. |
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 |