FDA.reportPublic FDA data

INFINITI® Factor II BioFilmChip® Microarray Magazine

Primary DI
00850009370044
Brand
INFINITI® Factor II BioFilmChip® Microarray Magazine
Company
AUTOGENOMICS, INC
Model
01-1020-01
Catalog number
01-1020-01
Device description
Genotyping system for the detection of Factor II (Prothrombin) G20210A 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
NPRTEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR
NSUInstrumentation for clinical multiplex test systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
00850009370044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850009370044008500093700448500093700440850009370044

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation factor II (prothrombin) mutation 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 the coagulation factor II (prothrombin) G20210A mutation associated with venous thrombosis, using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius8 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
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
00850009370112INFINITI® Factor II-V Leiden Intellipac® Reagent Module01-2050-0101-2050-012019-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336206355cobas® 6800 systemRoche Molecular Systems, Inc.NSU2026-03-26
07613336206362cobas® 8800 systemRoche Molecular Systems, Inc.NSU2026-03-26
04049016126034EUROArrayScanEUROIMMUN Medizinische Labordiagnostika AGNSU2025-12-19
00851458005327SPOTFIRE Control Station - ITARBIOFIRE DEFENSE, LLCNSU2025-12-16
00851458005334SPOTFIRE Control Station - non-ITARBIOFIRE DEFENSE, LLCNSU2025-12-16
07332940009519GeneXpert® CEPHEIDNPR2025-11-21
05060441760005binx ioBINX HEALTH LIMITEDNSU2025-09-03
10190302019897Applied BioSystems™ ABY™ Dye Spectral Calibration Plate for Multiplex qPCR, FastLIFE TECHNOLOGIES HOLDINGS PTE. LTD.NSU2025-08-19
10190302019903Applied BioSystems™ JUN™ Dye Spectral Calibration Plate for Multiplex qPCR, FastLIFE TECHNOLOGIES HOLDINGS PTE. LTD.NSU2025-08-19
00840487101858LIAISON PLEX Gram-Positive Blood Culture AssayLUMINEX CORPORATIONNSU2025-07-11
08033891322670CHORUS EVODIESSE DIAGNOSTICA SENESE SPANSU2025-07-01
00840487101841LIAISON PLEX Gram-Negative Blood Culture AssayLUMINEX CORPORATIONNSU2025-06-11
04719880531103QLociLIFEOS GENOMICS CORPORATIONNSU2025-04-30
00850063063005DASH® Rapid PCR InstrumentNuclein, LLCNSU2025-01-06
00856826006203Applied BiosystemsAffymetrix, Inc.NSU2024-12-24
15420045517059Aptima®Hologic, Inc.NSU2024-12-19
15420045517066Aptima®Hologic, Inc.NSU2024-12-19
15420045517073Aptima®Hologic, Inc.NSU2024-12-19
15420045517080Aptima®Hologic, Inc.NSU2024-12-19
06974849369403EudemonTM AIO800Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NSU2024-11-14
00815381020727BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel MiniBIOFIRE DIAGNOSTICS, LLCNSU2024-07-26
00840487101957LIAISON PLEX® ChassisLUMINEX CORPORATIONNSU2024-06-20
00840487101964LIAISON PLEX® Chassis (Refurbished)LUMINEX CORPORATIONNSU2024-06-20
00840487101971LIAISON PLEX® ModuleLUMINEX CORPORATIONNSU2024-06-20
00840487101988LIAISON PLEX® Module (Refurbished)LUMINEX CORPORATIONNSU2024-06-20
00875197006926cobas Buffer Negative Control KitRoche Diagnostics GmbHNSU2024-06-05
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCNSU2024-05-03
00382904439767BD Vaginal Panel on BD COR SystemBECTON, DICKINSON AND COMPANYNSU2024-04-02
00851458005297FILMARRAY® COMMERCIAL LAPTOPBIOFIRE DEFENSE, LLCNSU2024-03-19
00195126000871Aptiva® System Cleaning Solution KitINOVA DIAGNOSTICS, INC.NSU2024-03-18