FDA.reportPublic FDA data

CyFlow™ CD19 APC

Primary DI
08594208066439
Brand
CyFlow™ CD19 APC
Company
EXBIO Praha, a.s.
Model
AG992046
Catalog number
AG992046
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
2022-11-08
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
08594208066439PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08594208066439085942080664398594208066439

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Total Volume1Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-879-7639cytometry@sysmex.com

Regulatory Flags#

DUNS number
495024965
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08595715450544CyFlow™ CD200 PE-Cy7BJ982090BJ9820902025-10-01
08595715447759CyFlow™ CD34 Pacific Blue™CP434822CP4348222025-04-07
08595715448619CyFlow™ CD10 PE-Cy7AL156483AL1564832025-04-07
08595715448633CyFlow™ CD56 PE-Cy7BJ085346BJ0853462025-04-07
08595715449524CyFlow™ IFN-gamma FITCBR971706BR9717062025-04-07
08595715450773CyFlow™ CD7 PE-Cy7AG597425AG5974252025-04-07
08595715447780CyFlow™ TdT FITCCE881363CE8813632024-12-06
08595715448602CyFlow™ CD3 Pacific Orange™BL302014BL3020142024-12-06
08595715448626CyFlow™ CD14 PE-Cy7BW161805BW1618052024-12-06
08595715448640CyFlow™ IgG (Fab) PE-Cy7CH907651CH9076512024-12-06
08595715448657CyFlow™ CD11b APC-Cy7CB102695CB1026952024-12-06
08595715448664CyFlow™ CD11c FITCAG248041AG2480412024-12-06
08595715448671CyFlow™ CD23 PerCP-Cy5.5BR282546BR2825462024-12-06
08595715448688CyFlow™ CD28 APCCA369784CA3697842024-12-06
08595715448695CyFlow™ HLA-DR APC-Cy7BT262476BT2624762024-12-06
08595715448701CyFlow™ CD62P BiotinBN849744BN8497442024-12-06
08595715447728CyFlow™ CD5 Alexa Fluor™ 700CZ502888CZ5028882024-07-04
08595715447735CyFlow™ CD26 PEAT758612AT7586122024-07-04
08595715447742CyFlow™ IgD PEBM781357BM7813572024-07-04
08595715447766CyFlow™ CD38 PE-Cy7AM704693AM7046932024-07-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08595715450544CyFlow™ CD200 PE-Cy7EXBIO Praha, a.s.MVU2025-10-01
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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
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08436548984946CD45-APC-C750™CYTOGNOS SLMVU2023-01-17
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