FDA.reportPublic FDA data

CytoCell

Primary DI
05055844934894
Brand
CytoCell
Company
CYTOCELL LIMITED
Model
CDA-LPH013
Device description
KMT2A Breakapart FISH Probe Kit PDx
Published
2025-09-22
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
SFSRevumenib Eligibility Detection System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SFSRevumenib Eligibility Detection SystemHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN240067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN240067000KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)Cytocell Limited2025-09-19SFS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055844934894PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055844934894050558449348945055844934894

GMDN Terms#

Term, Definition table
TermDefinition
B-cell malignancy 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 detect and/or monitor B-cell malignancies. Genetic changes associated with B-cell malignancies are typically associated with chromosomal translocations and gene rearrangements involving various genes/loci such as cyclin D1 (CCND1), immunoglobulin heavy or light chain genes (e.g., IGH, IGK, IGL), myc, and B-cell lymphoma genes (e.g., BCL1, BCL2).

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