FDA.report

CytoCell

Primary DI
05055844919389
Brand
CytoCell
Company
CYTOCELL LIMITED
Model
LPE001R-A
Device description
Chromosome 1 Classical Satellite Probe (Concentrated) (ASR)
Published
2025-03-27
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

Related Records

Contact Domains

Product Codes

CodeName
MVUReagents, Specific, Analyte

Product Code Classifications

CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055844919389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055844919389050558449193895055844919389

GMDN Terms

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

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

Contacts

PhoneEmail
914 467 5285contact@ogt.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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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