FDA.reportPublic FDA data

Colcemid Solution

Primary DI
00810195240408
Brand
Colcemid Solution
Company
IRVINE SCIENTIFIC, LLC
Model
9311-10ML
Catalog number
9311
Device description
Colcemid Solution 10µg/mL in Hank’s Balanced Salts
Published
2025-06-02
Public version status
New
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
00810195240408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810195240408008101952404088101952404080810195240408

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
121584789
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
00810195241597Fast Warm-NX with Gentamicin2x20ML901962026-01-09
00810195241603Fast Warm-NX with Gentamicin6x2ML901962026-01-09
00810195240477Continuous Single Culture Complete (CSCM-C) with Gentamicin and HSA 90165-2x20ML901652025-06-02
00810195240002cryo-GO Vitrification Device - Red (Pack of 10)70307-R70307-R2025-06-02
00810195240019cryo-GO Vitrification Device - Yellow (Pack of 10)70308-Y70308-Y2025-06-02
00810195240026cryo-GO Vitrification Device - Blue (Pack of 10)70309-B70309-B2025-06-02
00810195240033cryo-GO Vitrification Device - Green (Pack of 10)70310-G70310-G2025-06-02
00810195240040cryo-GO Vitrification Device - Purple (Pack of 10)70311-P70311-P2025-06-02
00810195240057cryo-GO Vitrification Device - Red (Pack of 50)70312-R70312-R2025-06-02
00810195240064cryo-GO Vitrification Device - Yellow (Pack of 50)70313-Y70313-Y2025-06-02
00810195240071cryo-GO Vitrification Device - Blue (Pack of 50)70314-B70314-B2025-06-02
00810195240088cryo-GO Vitrification Device - Green (Pack of 50)70315-G70315-G2025-06-02
00810195240095cryo-GO Vitrification Device - Purple (Pack of 50)70316-P70316-P2025-06-02
00810195240101SSS-NX (Serum Substitute Supplement - NX)90194-100ML901942025-06-02
00810195240118SSS-NX (Serum Substitute Supplement - NX)90194-12x10ML901942025-06-02
008101952401257% PVP Solution with HSA90121-5x0.5ML901212025-06-02
0081019524013210% PVP Solution with HSA90123-5x0.5ML901232025-06-02
00810195240149Arctic Sperm Cryopreservation Medium90170-12x5ML901702025-06-02
00810195240156Refrigeration Medium - Test Yolk Buffer (TYB) with Gentamicin90129-20x5ML901292025-06-02
00810195240163Freezing Medium Test Yolk Buffer (TYB) with Glycerol and Gentamicin90128-20x5ML901282025-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00893727002682Chang AmnioFUJIFILM IRVINE SCIENTIFIC, INC.KIQ2021-04-19