FDA.reportPublic FDA data

Pre-Hypotonic Solution

Primary DI
05060174130083
Brand
Pre-Hypotonic Solution
Company
GENIAL HELIX LTD
Model
GGS - JL007
Catalog number
GGS - JL007
Device description
Pre-Hypotonic Solution is to be used before the hypotonic stage of a blood or bone marrow harvest; pre-hypotonic solution makes the hypotonic stepmore effective by circumventing the tendency of chromosomes to clump or to under-spread.
Published
2023-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KIQKit, Culture, Chromosome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIQKit, Culture, ChromosomeHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060174130083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060174130083050601741300835060174130083

GMDN Terms#

Term, Definition table
TermDefinition
Assay development analyte-specific reagent IVDAn antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological specimen for the development of a laboratory developed test (LDT) or commercial in vitro diagnostic medical device (IVD). Commonly referred to as an analyte specific reagent (ASR), it is neither labelled with instructions for use nor diagnostic or performance claims.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
219918136
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060174130021Anticlotting ReagentGGS - JL001GGS - JL0012023-09-18
05060174130038Erythrocyte Lysis SolutionGGS - JL009GGS - JL0092023-09-18
05060174130045Lymphocyte Growth SupplementGGS - JL002LGGS - JL002L2023-09-18
05060174130052Bone Marrow Growth SupplementGGS - JL002GGS - JL0022023-09-18
05060174130069Chromosome Resolution AdditiveGGS - JL003GGS - JL0032023-09-18
05060174130076Metaphase Arresting SolutionGGS - JL008GGS - JL0082023-09-18
05060174130090Buffered Hypotonic SolutionGGS - JL006GGS - JL0062023-09-18
05060174130106Optimal Hypotonic SolutionGGS - JL005GGS - JL0052023-09-18
05060174130113Cytoclear Cytoplasm RemoverGGS - JL004GGS - JL0042023-09-18
05060174130137Skin Growth SupplementGGS - JL012GGS - JL0122023-09-18
05060174130144Lymphoma Growth SupplementGGS - JL011GGS - JL0112023-09-18
05060174130151Product of Conception Growth SupplementGGS - JL013GGS - JL0132023-09-18
05060174130182Solid Tumor Growth SupplementGGS - JL010GGS - JL0102023-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810195240408Colcemid SolutionIRVINE SCIENTIFIC, LLCKIQ2025-06-02
05060174130021Anticlotting ReagentGENIAL HELIX LTDKIQ2023-09-18
05060174130038Erythrocyte Lysis SolutionGENIAL HELIX LTDKIQ2023-09-18
05060174130045Lymphocyte Growth SupplementGENIAL HELIX LTDKIQ2023-09-18
05060174130052Bone Marrow Growth SupplementGENIAL HELIX LTDKIQ2023-09-18
05060174130069Chromosome Resolution AdditiveGENIAL HELIX LTDKIQ2023-09-18
05060174130076Metaphase Arresting SolutionGENIAL HELIX LTDKIQ2023-09-18
05060174130090Buffered Hypotonic SolutionGENIAL HELIX LTDKIQ2023-09-18
05060174130106Optimal Hypotonic SolutionGENIAL HELIX LTDKIQ2023-09-18
05060174130113Cytoclear Cytoplasm RemoverGENIAL HELIX LTDKIQ2023-09-18
05060174130137Skin Growth SupplementGENIAL HELIX LTDKIQ2023-09-18
05060174130144Lymphoma Growth SupplementGENIAL HELIX LTDKIQ2023-09-18
05060174130151Product of Conception Growth SupplementGENIAL HELIX LTDKIQ2023-09-18
05060174130182Solid Tumor Growth SupplementGENIAL HELIX LTDKIQ2023-09-18
00857515006306Colcemid SolutionFUJIFILM IRVINE SCIENTIFIC, INC.KIQ2021-04-23
00893727002415Colcemid SolutionFUJIFILM IRVINE SCIENTIFIC, INC.KIQ2021-04-23
00893727002446Chang Medium BFUJIFILM IRVINE SCIENTIFIC, INC.KIQ2021-04-21
00893727002453Chang Medium CFUJIFILM IRVINE SCIENTIFIC, INC.KIQ2021-04-21
00893727002460Chang Medium CFUJIFILM IRVINE SCIENTIFIC, INC.KIQ2021-04-21
00893727002484Chang Medium in SITUFUJIFILM IRVINE SCIENTIFIC, INC.KIQ2021-04-21
00893727002767Chang Medium in SITUFUJIFILM IRVINE SCIENTIFIC, INC.KIQ2021-04-21
00857515006108Chang Medium BFUJIFILM IRVINE SCIENTIFIC, INC.KIQ2021-04-20
00857515006153Chang Medium BMC with GentamicinFUJIFILM IRVINE SCIENTIFIC, INC.KIQ2021-04-20
00893727002392Chang Medium BMC with GentamicinFUJIFILM IRVINE SCIENTIFIC, INC.KIQ2021-04-20
00857515006160Chang Medium MF with GentamicinFUJIFILM IRVINE SCIENTIFIC, INC.KIQ2021-04-19
00893727002408Chang Medium MF with GentamicinFUJIFILM IRVINE SCIENTIFIC, INC.KIQ2021-04-19
00893727002477Chang Medium DFUJIFILM IRVINE SCIENTIFIC, INC.KIQ2021-04-19
00893727002668Chang Marrow Bone Marrow Culture Medium with GentamicinFUJIFILM IRVINE SCIENTIFIC, INC.KIQ2021-04-19
00893727002675Chang Marrow Bone Marrow Culture Medium with GentamicinFUJIFILM IRVINE SCIENTIFIC, INC.KIQ2021-04-19
00893727002682Chang AmnioFUJIFILM IRVINE SCIENTIFIC, INC.KIQ2021-04-19