FDA.reportPublic FDA data

PerCP anti-human CD61

Primary DI
00810034703170
Brand
PerCP anti-human CD61
Company
BIOLEGEND, INC.
Model
988004
Catalog number
988004
Device description
URL: https://www.biolegend.com/en-us/products/percp-anti-human-cd61-24116
Published
2026-08-07
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

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
00810034703170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810034703170008100347031708100347031700810034703170

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 Volume0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
858-768-5800tech-BioLegend@revvity.com

Regulatory Flags#

DUNS number
119240658
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
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810034704252FITC anti-human TNF-Alpha9868089868082026-07-28
00810034704320PE anti-human IL-29899469899462026-07-28
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

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Primary DI, Brand, Company table
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03661540953217DSQ Alert Hepatitis E Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953224DSQ Alert Hepatitis E Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953279DSQ Alert Mycoplasma pneumoniae Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953286DSQ Alert Mycoplasma pneumoniae Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
00810034704252FITC anti-human TNF-AlphaBIOLEGEND, INC.MVU2026-07-28
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