FDA.reportPublic FDA data

Array Card Clip

Primary DI
10190302007399
Brand
Array Card Clip
Company
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
Model
4452205
Device description
VIIA 7 DX ARRAY CARD BUCKET
Published
2018-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OULThermocycler, generic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OULThermocycler, GenericClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190302007399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019030200739910190302007399

GMDN Terms#

Term, Definition table
TermDefinition
PCR instrument calibrator kit IVDA collection of reagents and other associated materials intended to be used to calibrate or verify the performance of a polymerase chain reaction (PCR) analyser to ensure its proper function prior to analysis/processing of clinical samples.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
628548377
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190302017794Ion Torrent™ Genexus™ Dx Integrated SequencerA532562025-10-13
10190302017800Ion Torrent™ Genexus™ Dx Purification instrumentA532572025-10-13
10190302019897Applied BioSystems™ ABY™ Dye Spectral Calibration Plate for Multiplex qPCR, FastA654872025-08-19
10190302019903Applied BioSystems™ JUN™ Dye Spectral Calibration Plate for Multiplex qPCR, FastA654882025-08-19
10190302018883Ion Torrent Genexus Dx Software6.8A563322025-07-24
10190302018944VeritiPro Dx Thermal CyclerA558262023-05-25
10190302017329Applied BiosystemsA512202022-05-01
10190302017336Applied BiosystemsA512222022-05-01
10190302016148QuantStudio™ 7 Pro Dx Real-Time PCR SystemA507452021-12-10
10190302016155QuantStudio™ 7 Pro Dx 96-Well BlockA511952021-12-10
10190302016162QuantStudio™ 7 Pro Dx 96-Well Heated CoverA511972021-12-10
10190302015592Applied Biosystems™ QuantStudio™ 5 Dx Real-Time PCR SystemA473242021-02-01
101903020002227500 Fast Dx Real-Time PCR  Instrument75032016-08-01
10190302000512Veriti™ Dx 96-Well Fast Thermal Cycler99112016-08-01
10190302000529Veriti™ Dx 96-Well Thermal Cycler99122016-08-01
10190302000536Veriti™ Dx 384-Well Thermal Cycler99132016-08-01
10190302000857Ion One Touch™ DxONE TOUCH DX2016-08-01
10190302000864Ion One Touch™ ES DxONE TOUCH ES DX2016-08-01
10190302000697QuantStudioTM Dx Real-Time PCR Instrument87882016-08-01
10190302000734Lamp, Halogen RC, IVD44809142016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974689625134TARGETINGONETargetingOne Technology (Beijing) CorporationOUL2023-10-20
10190302018944VeritiPro Dx Thermal CyclerLIFE TECHNOLOGIES HOLDINGS PTE. LTD.OUL2023-05-25
10190302000512Veriti™ Dx 96-Well Fast Thermal CyclerLIFE TECHNOLOGIES HOLDINGS PTE. LTD.OUL2016-08-01
10190302000529Veriti™ Dx 96-Well Thermal CyclerLIFE TECHNOLOGIES HOLDINGS PTE. LTD.OUL2016-08-01
10190302000536Veriti™ Dx 384-Well Thermal CyclerLIFE TECHNOLOGIES HOLDINGS PTE. LTD.OUL2016-08-01