FDA.report

CyFlow™ CD45R0 FITC

Primary DI
08594208068617
Brand
CyFlow™ CD45R0 FITC
Company
EXBIO Praha, a.s.
Model
BC287359
Catalog number
BC287359
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
2022-11-09
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
08594208068617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08594208068617085942080686178594208068617

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
08595715447773CyFlow™ IgM PerCP-Cy5.5BM298540BM2985402024-07-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
03661540953118DSQ Alert Measles Primer Mix ASR, 48 rxnElitechgroup Mdx LLCMVU2026-03-24
03661540953125DSQ Alert Measles Probe Mix ASR, 48 rxnElitechgroup Mdx LLCMVU2026-03-24
03661540953132DSQ Alert RNase P Primer Mix ASR 48 rxnElitechgroup Mdx LLCMVU2026-03-24
03661540953163DSQ Alert RNase P Probe Mix ASR 48 rxnElitechgroup Mdx LLCMVU2026-03-24
04251315801035MetaSystems ProbesMetaSystems Probes GmbHMVU2026-03-17
05055844935525CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935532CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935549CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935556CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935563CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935570CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935617CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935624CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
00850051429936Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-02-26
00850051429882Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-01-24
00850051429899Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-01-24
05700575018107Monoclonal Mouse Anti-Human Integrin Beta-6, Clone 6.2A1AGILENT TECHNOLOGIES, INC.MVU2026-01-21
M663DF300120DiskFISHCELLAY, INC.MVU2026-01-06
M663DF300129DiskFISHCELLAY, INC.MVU2026-01-06
M663DF400590DiskFISHCELLAY, INC.MVU2026-01-06
M663DF402440DiskFISHCELLAY, INC.MVU2026-01-06
M663CKOF300120OligoFISHCELLAY, INC.MVU2026-01-06
M663CKOF302510OligoFISHCELLAY, INC.MVU2026-01-06
M663CKOF400590OligoFISHCELLAY, INC.MVU2026-01-06
M663OF4005903001OligoFISHCELLAY, INC.MVU2026-01-06
M663CKOF402440OligoFISHCELLAY, INC.MVU2026-01-06
00810034704009PE anti-human TdTBIOLEGEND, INC.MVU2025-12-22
00810034704016FITC anti-human TdTBIOLEGEND, INC.MVU2025-12-22
00810034704047Pacific Blue™ anti-human Granzyme BBIOLEGEND, INC.MVU2025-12-22
00810034704054Spark Violet™ 538 anti-human HLA-DRBIOLEGEND, INC.MVU2025-12-22