FDA.reportPublic FDA data

PerCP/Cyanine5.5 anti-human CD117 (c-kit)

Primary DI
00810034702050
Brand
PerCP/Cyanine5.5 anti-human CD117 (c-kit)
Company
BIOLEGEND, INC.
Model
983312
Catalog number
983312
Device description
URL: https://www.biolegend.com/en-us/products/percp-cyanine5-5-anti-human-cd117-c-kit-22077
Published
2022-08-05
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
00810034702050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810034702050008100347020508100347020500810034702050

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
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
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
00810034704030APC anti-human TNF-Alpha9868069868062025-12-12
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
00810034703828APC anti-human TdT9899029899022025-07-31
00810034703835APC anti-human CD127 9860109860102025-07-31
00810034703842PE/Cyanine5 anti-human CD459823249823242025-07-31
00810034703613APC anti-human CD2799816049816042025-03-27
00810034703804APC anti-human CD138 9870049870042025-03-27
00810034703811PE/Cyanine7 anti-human CD294 9838049838042025-03-27

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Primary DI, Brand, Company table
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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
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05055844935549CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
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05055844935570CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
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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