INFINITI® Factor II-V Leiden Amplification Mix - Genotyping system for the detection of Factor II - AUTOGENOMICS, INC

Duns Number:027914535

Device Description: Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations

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More Product Details

Catalog Number

01-3050-01

Brand Name

INFINITI® Factor II-V Leiden Amplification Mix

Version/Model Number

01-3050-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K060564

Product Code Details

Product Code

NPQ

Product Code Name

TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR

Device Record Status

Public Device Record Key

7505a50f-5fc9-4612-bf1e-c25063d90c2d

Public Version Date

October 31, 2019

Public Version Number

1

DI Record Publish Date

October 23, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AUTOGENOMICS, INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 19