FDA.reportPublic FDA data

KingFisher™ Apex Dx 96 Deep Well Head

Primary DI
10190302019262
Brand
KingFisher™ Apex Dx 96 Deep Well Head
Company
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
Model
B24079930
Published
2023-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JJHClinical sample concentrator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJHClinical Sample ConcentratorClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190302019262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019030201926210190302019262

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid sample preparation instrument IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the automated pre-analytical preparation of samples for downstream nucleic acid analysis. The instrument may be used to prepare various sample types through one or more pre-analytical steps which may include cell disruption, lysis, nucleic acid extraction, enzymatic digestion and/or nucleic acid purification.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
628548377
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
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
04053228049982QIAsymphony® ConnectQIAGEN GmbHJJH2026-07-28
B708ABFVR020XCELLAPEX BIOLOGIX , LLCJJH2026-03-26
06955792702844Nucleic Acid Extraction and Purification Kit 1.0Sansure Biotech Inc.JJH2026-03-25
06955792702851Nucleic Acid Extraction and Purification Kit 1.0Sansure Biotech Inc.JJH2026-03-25
06955792702868Nucleic Acid Extraction and Purification Kit 2.0Sansure Biotech Inc.JJH2026-03-25
06955792702875Nucleic Acid Extraction and Purification Kit 2.0Sansure Biotech Inc.JJH2026-03-25
06955792702882Nucleic Acid Extraction and Purification Kit 3.0Sansure Biotech Inc.JJH2026-03-25
06955792702899Nucleic Acid Extraction and Purification Kit 3.0Sansure Biotech Inc.JJH2026-03-25
04053228040576EZ2 Connect MDxQIAGEN GmbHJJH2026-03-03
00849811081835Maxwell® CSC Rapid ccfDNA KitPROMEGA CORPORATIONJJH2026-02-16
00849811083778Maxwell® CSC XtractAll FFPE DNA/RNA KitPROMEGA CORPORATIONJJH2026-02-16
04719882810046IntelliPrep TRIO 240 Sample Preparation SystemPlexBio Co., Ltd.JJH2026-01-28
04719882810237IntelliPrep Blood Genomic DNA Extraction Kit PlexBio Co., Ltd.JJH2026-01-28
04719882810268IntelliPrep FFPE DNA Extraction Kit PlexBio Co., Ltd.JJH2026-01-28
04719882810282IntelliPrep FFPE RNA Extraction KitPlexBio Co., Ltd.JJH2026-01-28
04719882810299IntelliPrep cfDNA Extraction KitPlexBio Co., Ltd.JJH2026-01-28
04719880121397TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880121403TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880121441TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880121458TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122097TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122103TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122158TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122165TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122370TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122387TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122431TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122660TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122707TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122882TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07