FDA.reportPublic FDA data

CytoCell

Primary DI
05055844923898
Brand
CytoCell
Company
CYTOCELL LIMITED
Model
USA-LPH026
Device description
AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion FISH Probe Kit (IVD (USA))
Published
2025-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QDIFish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDIFish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic MalignanciesMedical Genetics2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN170070000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN170070000MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit,Del(5q)Deletion FISH Probe Kit; Del(7q)Deletion FISH Probe KitCytocell, Ltd.2018-12-21QDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055844905900PreviousGS10
05055844923898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055844905900050558449059005055844905900
05055844923898050558449238985055844923898

GMDN Terms#

Term, Definition table
TermDefinition
Acute myeloid leukaemia (AML) genetic mutation IVD, probeA defined piece of single-stranded nucleic acid which is used to identify specific complementary-sequence nucleic acid molecules in an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict acute myeloid leukaemia (AML) based on changes at the gene or chromosomal level which may include FLT3 gene mutations, NPM1 gene mutations, t(8;21), inv(16) and/or t(15;17).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store the probe vial in the dark. Ensure that exposure of the probe to laboratory lights is limited at all times.
Storage Environment Temperature-25 Degrees Celsius-15 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
914 467 5285contact@ogt.com

Regulatory Flags#

DUNS number
232477914
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055844935686CytoCell myProbesMPD515612026-04-20
05055844935693CytoCell myProbesMPD515622026-04-20
05055844935709CytoCell myProbesMPD515632026-04-20
05055844935662CytoCell myProbesMPH48212026-04-11
05055844935679CytoCell myProbesMPH48222026-04-11
05055844935525CytoCell myProbesMPP605812026-03-17
05055844935532CytoCell myProbesMPP605822026-03-17
05055844935549CytoCell myProbesMPP605912026-03-17
05055844935556CytoCell myProbesMPP605922026-03-17
05055844935563CytoCell myProbesMPP610712026-03-17
05055844935570CytoCell myProbesMPP610722026-03-17
05055844935617CytoCell myProbesMPD29612026-03-17
05055844935624CytoCell myProbesMPD29622026-03-17
05055844935310CytoCell myProbesMPD377512026-02-12
05055844935327CytoCell myProbesMPD377522026-02-12
05055844935334CytoCell myProbesMPP55622026-02-12
05055844935341CytoCell myProbesMPP55612026-02-12
05055844935358CytoCell myProbesMPH563212026-02-12
05055844935365CytoCell myProbesMPH563222026-02-12
05055844935372CytoCell myProbesMPH563232026-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055844923836CytoCellCYTOCELL LIMITEDQDI2025-03-26
05055844923843CytoCellCYTOCELL LIMITEDQDI2025-03-26
05055844923850CytoCellCYTOCELL LIMITEDQDI2025-03-26
05055844923867CytoCellCYTOCELL LIMITEDQDI2025-03-26
05055844923874CytoCellCYTOCELL LIMITEDQDI2025-03-26
05055844923881CytoCellCYTOCELL LIMITEDQDI2025-03-26
05055844923904CytoCellCYTOCELL LIMITEDQDI2025-03-26
05055844905900CytoCellCYTOCELL LIMITEDQDI2021-07-12
05055844905917CytoCellCYTOCELL LIMITEDQDI2021-07-12
05055844905924CytoCellCYTOCELL LIMITEDQDI2021-07-12
05055844905931CytoCellCYTOCELL LIMITEDQDI2021-07-12
05055844905948CytoCellCYTOCELL LIMITEDQDI2021-07-12
05055844905955CytoCellCYTOCELL LIMITEDQDI2021-07-12
05055844905962CytoCellCYTOCELL LIMITEDQDI2021-07-12
05055844905979CytoCellCYTOCELL LIMITEDQDI2021-07-12
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05055844901568Cytocell AquariusCYTOCELL LIMITEDQDI2019-01-28
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05055844901599Cytocell AquariusCYTOCELL LIMITEDQDI2019-01-28
05055844901605Cytocell AquariusCYTOCELL LIMITEDQDI2019-01-28