FDA.report

CyFlow™ CD123 FITC

Primary DI
08594208067733
Brand
CyFlow™ CD123 FITC
Company
EXBIO Praha, a.s.
Model
AV296074
Catalog number
AV296074
Device description
The reagent may have application in various test methodologies, including Flow Cytometry. Vial has sufficient volume for 100 tests, if used at 10 uL / test. The reagent is provided in stabilizing phosphate buffered saline (PBS) solution, pH 7.4, containing 0.09% (w/v) sodium azide.
Published
2022-11-07
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
08594208067733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08594208067733085942080677338594208067733

GMDN Terms

TermDefinition
Multiple CD cell marker IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of multiple cluster of differentiation (CD) cell markers in a clinical specimen, including associated percentage and/or enumeration of specific cell populations.

Device Sizes

TypeValueUnit
Total Volume1Milliliter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1-888-879-7639cytometry@sysmex.com

Regulatory Flags

DUNS number
495024965
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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