FDA.reportPublic FDA data

CytoCell myProbes

Primary DI
05055844912373
Brand
CytoCell myProbes
Company
CYTOCELL LIMITED
Model
MPH9751
Device description
13q14.3 in Orange Spectrum
Published
2022-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVUReagents, Specific, Analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055844912373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055844912373050558449123735055844912373

GMDN Terms#

Term, Definition table
TermDefinition
Assay development analyte-specific reagent IVDAn antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological specimen for the development of a laboratory developed test (LDT) or commercial in vitro diagnostic medical device (IVD). Commonly referred to as an analyte specific reagent (ASR), it is neither labelled with instructions for use nor diagnostic or performance claims.

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
9144675285probes@cytocell.com

Regulatory Flags#

DUNS number
232477914
Device count
1
Premarket exempt
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
08595715450544CyFlow™ CD200 PE-Cy7EXBIO Praha, a.s.MVU2025-10-01
08719327450949Anti-HbF PUREIQ Products B.V.MVU2023-01-26
08719327450956Anti-HbF FITCIQ Products B.V.MVU2023-01-26
08719327450963Anti-HbF R-PEIQ Products B.V.MVU2023-01-26
08719327450970Anti-HbF Dy-410IQ Products B.V.MVU2023-01-26
08719327450987anti-HbS PUREIQ Products B.V.MVU2023-01-26
08719327450994anti-HbS FITCIQ Products B.V.MVU2023-01-26
08719327451014CD163 PURE IQ Products B.V.MVU2023-01-26
08719327451021CD163 FITCIQ Products B.V.MVU2023-01-26
08719327451038CD163 R-PEIQ Products B.V.MVU2023-01-26
08719327451045CD163 BiotinIQ Products B.V.MVU2023-01-26
08719327451052CD64 PUREIQ Products B.V.MVU2023-01-26
08719327451069CD64 CyQIQ Products B.V.MVU2023-01-26
08719327451076CD64 FITCIQ Products B.V.MVU2023-01-26
08719327451083CD64 R-PEIQ Products B.V.MVU2023-01-26
08719327451090CD64 R-PEIQ Products B.V.MVU2023-01-26
08436548983413CD38-multi-epitope-FITCCYTOGNOS SLMVU2023-01-17
08436548984946CD45-APC-C750™CYTOGNOS SLMVU2023-01-17
10190302007276PRIMER 100 NMOL LIQ TELIFE TECHNOLOGIES CORPORATIONMVU2018-09-18
10190302007283PRIMER 100 NMOL DRYLIFE TECHNOLOGIES CORPORATIONMVU2018-09-18
10190302009492Mouse IgM Purified AntibodyLIFE TECHNOLOGIES CORPORATIONMVU2018-07-02
10190302009508Mouse IgM FITC ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-07-02
10190302009515Mouse IgM R-PE ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-07-02
10190302010405Human CD14 TRI-COLOR® ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-05-06
10190302010412Human CD14 Biotin ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-05-06
10190302010429Human CD14 PE-Texas Red® ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-05-06
10190302010436Human CD14 PE-Cy®5.5 ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-05-06
10190302010443Human CD14 APC- Alexa Fluor® 750 Conj.LIFE TECHNOLOGIES CORPORATIONMVU2018-05-06
10190302010450Human CD14 Pacific Blue™ ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-05-06
10190302010467Human CD14 Alexa Fluor® 700 ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-05-06