FDA.reportPublic FDA data

INFINITI® Factor II-V Leiden Amplification Mix

Primary DI
00850009370129
Brand
INFINITI® Factor II-V Leiden Amplification Mix
Company
AUTOGENOMICS, INC
Model
01-3050-01
Catalog number
01-3050-01
Device description
Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations
Published
2019-10-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NPQTEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR
NPRTEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR
NSUInstrumentation for clinical multiplex test systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPQTest, Factor V Leiden Mutations, Genomic Dna PcrHematology2
NPRTest, Factor Ii G20210a Mutations, Genomic Dna PcrHematology2
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060564000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060564000INFINITI SYSTEMAutoGenomics, Inc.2007-02-07NPQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850009370129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850009370129008500093701298500093701290850009370129

GMDN Terms#

Term, Definition table
TermDefinition
Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict inherited thrombophilia, which may be associated with, but not limited to, the prothrombin 20,210 mutation and/or the Factor V Leiden mutation (activated protein C resistance), using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius-15 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(760)477-2248techsupport@autogenomics.com

Regulatory Flags#

DUNS number
027914535
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850009370249AvertD™ (96) PE Mix03-6560-0103-6560-012024-11-18
10850009370256AvertD™ (96) AMP Mix03-7560-0103-7560-012024-11-18
10850009370232AvertD™ (96) Tube03-5560-0103-5560-012024-11-18
30850009370243AvertD™ (96) PE Mix03-6560-0103-6560-012024-11-18
30850009370250AvertD™ (96) AMP Mix03-7560-0103-7560-012024-11-18
10850009370195AvertD™ Amplification Mix03-3560-0103-3560-012024-05-31
10850009370201AvertD™ Intellipac Reagent Module03-2560-0103-2560-012024-05-31
10850009370218AvertD™ BioFilmChip Microarray Magazine03-1560-0103-1560-012024-05-31
10850009370225AvertD™ Buccal Sample Collection Kit12-0610-0112-0610-012024-05-31
00850009370006INFINITI® PLUS ANALYZER10-0020-9910-0020-992019-10-23
00850009370013INFINITI® High Throughput System (HTS) ACE ANALYZER10-0030-9910-0030-992019-10-23
00850009370020INFINITI® High Throughput System (HTS) PROCESSOR10-0060-9910-0060-992019-10-23
00850009370037INFINITI® High Throughput System (HTS) INCUBATOR10-0070-9910-0070-992019-10-23
00850009370044INFINITI® Factor II BioFilmChip® Microarray Magazine01-1020-0101-1020-012019-10-23
00850009370051INFINITI® Factor II Intellipac® Reagent Module01-2020-0101-2020-012019-10-23
00850009370068INFINITI® Factor II Amplification Mix01-3020-0101-3020-012019-10-23
00850009370075INFINITI® Factor V Leiden BioFilmChip® Microarray Magazine01-1030-0101-1030-012019-10-23
00850009370082INFINITI® Factor V Leiden Intellipac® Reagent Module01-2030-0101-2030-012019-10-23
00850009370099INFINITI® Factor V Leiden Amplification Mix01-3030-0101-3030-012019-10-23
00850009370105INFINITI® Factor II-V Leiden BioFilmChip® Microarray Magazine01-1050-0101-1050-012019-10-23

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