FDA.reportPublic FDA data

PerCP/Cyanine5.5 anti-human CD4

Primary DI
00810034701220
Brand
PerCP/Cyanine5.5 anti-human CD4
Company
BIOLEGEND, INC.
Model
980810
Catalog number
980810
Device description
URL: https://www.biolegend.com/en-us/products/percpcyanine55-anti-human-cd4-18297
Published
2021-12-31
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
00810034701220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810034701220008100347012208100347012200810034701220

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume500Microliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
858-768-5800techserv@biolegend.com

Regulatory Flags#

DUNS number
119240658
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810034704306Spark Violet™ 538 anti-human CD49808269808262026-07-06
00810034704337Spark Violet™ 423 anti-human CD459823269823262026-07-06
00810034704085FITC anti-human Granzyme B9899249899242026-06-05
00810034704146PE/Cyanine7 anti-human Granzyme B9899269899262026-06-05
00810034704160APC anti-human CD649832169832162026-06-05
00810034704177FITC anti-human CD699852089852082026-06-05
00810034704191PE/Cyanine7 anti-human CD699852109852102026-06-05
00810034704214APC anti-human CD319890049890042026-06-05
00810034704245APC anti-human CD2749899429899422026-06-05
00810034704290APC/Fire™ 750 anti-human CD699852149852142026-06-05
00810034702951PerCP/Cyanine5.5 anti-human Beta2-microglobulin9878029878022026-06-01
00810034704061PE/Dazzle™ 594 anti-human CD229876069876062026-06-01
00810034704092FITC anti-human CD359899289899282026-06-01
00810034704108PE/Cyanine7 anti-human CD229876089876082026-06-01
00810034704139PE/Cyanine7 anti-human CD300e9899309899302026-06-01
00810034704009PE anti-human TdT9899169899162025-12-22
00810034704016FITC anti-human TdT9899189899182025-12-22
00810034704047Pacific Blue™ anti-human Granzyme B9899229899222025-12-22
00810034704054Spark Violet™ 538 anti-human HLA-DR9804249804242025-12-22
00810034703989Spark Red™ 718 anti-human CD19 9824229824222025-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810227730006Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730013Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730020Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730037Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429967Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429974Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429981Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429998Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730044Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730051Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730068Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730136Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730143Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730150Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730228Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
05055844935792CytoCell myProbesCYTOCELL LIMITEDMVU2026-07-19
00810227730198Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-13
00810227730204Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-13
00810034704306Spark Violet™ 538 anti-human CD4BIOLEGEND, INC.MVU2026-07-06
00810034704337Spark Violet™ 423 anti-human CD45BIOLEGEND, INC.MVU2026-07-06
15099590807160Anti-TCR Cß1 (TRBC1)-FITCIMMUNOTECHMVU2026-06-25
05055844935761CytoCell myProbesCYTOCELL LIMITEDMVU2026-06-06
05055844935778CytoCell myProbesCYTOCELL LIMITEDMVU2026-06-06
00810034704085FITC anti-human Granzyme BBIOLEGEND, INC.MVU2026-06-05
00810034704146PE/Cyanine7 anti-human Granzyme BBIOLEGEND, INC.MVU2026-06-05
00810034704160APC anti-human CD64BIOLEGEND, INC.MVU2026-06-05
00810034704177FITC anti-human CD69BIOLEGEND, INC.MVU2026-06-05
00810034704191PE/Cyanine7 anti-human CD69BIOLEGEND, INC.MVU2026-06-05
00810034704214APC anti-human CD31BIOLEGEND, INC.MVU2026-06-05
00810034704245APC anti-human CD274BIOLEGEND, INC.MVU2026-06-05