FDA.reportPublic FDA data

CytoCell myProbes

Primary DI
05055844935792
Brand
CytoCell myProbes
Company
CYTOCELL LIMITED
Model
MPA60251
Device description
20cen in Aqua Spectrum (ASR)
Published
2026-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
05055844935792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055844935792050558449357925055844935792

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 Temperature00

Contacts#

Phone, Email table
PhoneEmail
9144675285probes@cytocell.com

Regulatory Flags#

DUNS number
232477914
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055844935761CytoCell myProbesMPD65712026-06-06
05055844935778CytoCell myProbesMPD65722026-06-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810034703170PerCP anti-human CD61BIOLEGEND, INC.MVU2026-08-07
03661540953170DSQ Alert HT Adenovirus Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953187DSQ Alert HT Adenovirus Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953217DSQ Alert Hepatitis E Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953224DSQ Alert Hepatitis E Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953279DSQ Alert Mycoplasma pneumoniae Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953286DSQ Alert Mycoplasma pneumoniae Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
00810034704252FITC anti-human TNF-AlphaBIOLEGEND, INC.MVU2026-07-28
00810034704320PE anti-human IL-2BIOLEGEND, INC.MVU2026-07-28
00810227730211Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
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00810227730150Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
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00810227730198Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-13