FDA.reportPublic FDA data

CytoCell

Primary DI
05055844905948
Brand
CytoCell
Company
CYTOCELL LIMITED
Model
USA-LPH020
Catalog number
USA-LPH020
Device description
Del(20q) Deletion FISH Probe Kit
Published
2021-07-12
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
05055844901575PreviousGS10
05055844905948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055844901575050558449015755055844901575
05055844905948050558449059485055844905948

GMDN Terms#

Term, Definition table
TermDefinition
Myelodysplastic syndrome (MDS) 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 evaluate a clinical specimen to diagnose, monitor or predict myelodysplastic syndrome (MDS) based on changes at the gene or chromosome level, which may include deletion of the q arm of chromosome 20.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store the probe and counterstain vials in the dark. Ensure that exposure of the probe and counterstain 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 5285probes@cytocell.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
05055844923898CytoCellCYTOCELL LIMITEDQDI2025-03-26
05055844923904CytoCellCYTOCELL LIMITEDQDI2025-03-26
05055844905900CytoCellCYTOCELL LIMITEDQDI2021-07-12
05055844905917CytoCellCYTOCELL LIMITEDQDI2021-07-12
05055844905924CytoCellCYTOCELL LIMITEDQDI2021-07-12
05055844905931CytoCellCYTOCELL 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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05055844901582Cytocell AquariusCYTOCELL LIMITEDQDI2019-01-28
05055844901599Cytocell AquariusCYTOCELL LIMITEDQDI2019-01-28
05055844901605Cytocell AquariusCYTOCELL LIMITEDQDI2019-01-28