AUTOGENOMICS, INC

Address:1600 Faraday Avenue,Carlsbad,CA,92008,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Instrumentation for clinical multiplex test systems (NSU) (10) TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR (NPR) (3) TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR (NPQ) (3)

Premarket Exempt

No Yes

Clear

INFINITI® PLUS ANALYZER - 00850009370006 Catalog Number : 10-0020-99

Device Description : Instrumentation For Clinical Multiplex Test Systems

Device Class : 2

Duns Number: 027914535

Premarket Exempt : Yes

Product Code : NSU

Prescription Use : No

Device Count : 1

INFINITI® High Throughput System (HTS) ACE ANALYZER - 00850009370013 Catalog Number : 10-0030-99

Device Description : Instrumentation For Clinical Multiplex Test Systems

Device Class : 2

Duns Number: 027914535

Premarket Exempt : Yes

Product Code : NSU

Prescription Use : No

Device Count : 1

INFINITI® High Throughput System (HTS) PROCESSOR - 00850009370020 Catalog Number : 10-0060-99

Device Description : Instrumentation For Clinical Multiplex Test Systems

Device Class : 2

Duns Number: 027914535

Premarket Exempt : Yes

Product Code : NSU

Prescription Use : No

Device Count : 1

INFINITI® High Throughput System (HTS) INCUBATOR - 00850009370037 Catalog Number : 10-0070-99

Device Description : Instrumentation For Clinical Multiplex Test Systems

Device Class : 2

Duns Number: 027914535

Premarket Exempt : Yes

Product Code : NSU

Prescription Use : No

Device Count : 1

INFINITI® Factor II BioFilmChip® Microarray Magazine - 00850009370044 Catalog Number : 01-1020-01

Device Description : Genotyping system for the detection of Factor II (Prothrombin) G20210A mutations.

Device Class : 2

Duns Number: 027914535

Premarket Exempt : No

Product Code : NPR, NSU

Prescription Use : Yes

Device Count : 1

INFINITI® Factor II Intellipac® Reagent Module - 00850009370051 Catalog Number : 01-2020-01

Device Description : Genotyping system for the detection of Factor II (Prothrombin) G20210A mutation

Device Class : 2

Duns Number: 027914535

Premarket Exempt : No

Product Code : NPR, NSU

Prescription Use : Yes

Device Count : 1

INFINITI® Factor II Amplification Mix - 00850009370068 Catalog Number : 01-3020-01

Device Description : Genotyping system for the detection of Factor II (Prothrombin) G20210A mutations.

Device Class : 2

Duns Number: 027914535

Premarket Exempt : No

Product Code : NPR, NSU

Prescription Use : Yes

Device Count : 1

INFINITI® Factor V Leiden BioFilmChip® Microarray Magazine - 00850009370075 Catalog Number : 01-1030-01

Device Description : Genotyping system for the detection of the Factor V Leiden G1691A mutation

Device Class : 2

Duns Number: 027914535

Premarket Exempt : No

Product Code : NPQ, NSU

Prescription Use : Yes

Device Count : 1

INFINITI® Factor V Leiden Intellipac® Reagent Module - 00850009370082 Catalog Number : 01-2030-01

Device Description : Genotyping system for the detection of the Factor V Leiden G1691A mutation

Device Class : 2

Duns Number: 027914535

Premarket Exempt : No

Product Code : NPQ, NSU

Prescription Use : Yes

Device Count : 1

INFINITI® Factor V Leiden Amplification Mix - 00850009370099 Catalog Number : 01-3030-01

Device Description : Genotyping systme for the detection of the Factor V Leiden G1691A mutation

Device Class : 2

Duns Number: 027914535

Premarket Exempt : No

Product Code : NSU, NPQ

Prescription Use : Yes

Device Count : 1

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