FDA.reportPublic FDA data

KaryoMAX™ Colcemid™ Solution in HBSS

Primary DI
10190302003032
Brand
KaryoMAX™ Colcemid™ Solution in HBSS
Company
LIFE TECHNOLOGIES CORPORATION
Model
15212012
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

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
10190302003032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019030200303210190302003032

GMDN Terms#

Term, Definition table
TermDefinition
Cell culture medium IVDA liquid based tissue culture medium containing essential nutrients, sugars, amino acids and growth factors, intended to be used for the in-vitro maintenance, sustenance, and cultivation of human cells from a clinical specimen for diagnostic purposes.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118793157
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190302018449QuantStudio™ 7 Pro Dx Software, V3.0.0A546262022-09-12
10190302018159appliedbiosystems QuantStudioTM 7 Pro Dx SoftwareA52649, V2.0.02022-05-02
10190302017862QuantStudio™ 7 Pro Dx SoftwareA52015, V1.0.52021-12-10
10190302002691Dulbecco's Phosphate Buffered Saline (D-PBS)140401412016-08-04
10190302000635Dulbecco's Phosphate Buffered Saline (D-PBS)141901362016-08-01
10190302002684Hanks' Balanced Salt Solution (HBSS)140250922016-08-04
10190302002721Dulbecco's Phosphate Buffered Saline (D-PBS)140401332016-08-04
10190302002837Hanks' Balanced Salt Solution (HBSS)141701122016-08-04
10190302002844Hanks' Balanced Salt Solution (HBSS)141750952016-08-04
10190302002875Hanks' Balanced Salt Solution (HBSS)141750792016-08-04
10190302003018Dulbecco's Phosphate Buffered Saline (D-PBS)142000752016-08-04
10190302003858Hanks' Balanced Salt Solution (HBSS)240201172016-08-04
10190302000628Dulbecco's Phosphate Buffered Saline (D-PBS)140401172016-08-01
10190302002950Dulbecco's Phosphate Buffered Saline (D-PBS)141901442016-08-01
10190302019439Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution BufferA577402025-02-17
10190302018982TaqPath™ COVID-19, Flu A, Flu B, RSV Select AssayA564402025-02-17
10190302018999TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive Control9636122025-02-17
10190302019002TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control9636092025-02-17
10190302019019TaqPath™ 1-Step Select Master Mix (No ROX)A56518A561232025-02-17
10190302019026TaqPath™ COVID-19, Flu A, Flu B, RSV Select AssayA564412025-02-17

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
05060174130083Pre-Hypotonic 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