FDA.reportPublic FDA data

PerCP anti-human HLA-DR

Primary DI
00810034702081
Brand
PerCP anti-human HLA-DR
Company
BIOLEGEND, INC.
Model
980420
Catalog number
980420
Device description
URL: https://www.biolegend.com/en-us/products/percp-anti-human-hla-dr-21676
Published
2022-05-13
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
00810034702081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810034702081008100347020818100347020810810034702081

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
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00810034704016FITC anti-human TdT9899189899182025-12-22
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00810034704054Spark Violet™ 538 anti-human HLA-DR9804249804242025-12-22
00810034703989Spark Red™ 718 anti-human CD19 9824229824222025-12-12
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00810034703910PE/Cyanine7 anti-human IFN-Gamma9867069867062025-10-06
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00810034703972APC anti-human Granzyme B9899129899122025-10-06
00810034703996PE anti-human CD229876049876042025-10-06
00810034703927PE anti-human Granzyme B9899109899102025-09-25
00810034703941PE/Cyanine7 anti-human TNF-Alpha9868049868042025-09-25
00810034703965FITC anti-human IFN-Gamma9867089867082025-09-25
00810034703880Spark Violet™ 423 anti-human CD99872109872102025-09-11
00810034703903APC/Fire™ 750 anti-human CD7 9827169827162025-09-11
00810034703866APC/Fire™ 750 anti-human CD439899069899062025-08-25
00810034703873PE anti-human CD3269899089899082025-08-25
00810034703897Spark Violet™ 423 anti-human CD21 9813049813042025-08-25

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