FDA.report

CD117-APC

Primary DI
04049934134432
Brand
CD117-APC
Company
Miltenyi Biotec B.V. & Co. KG
Model
170-081-016
Device description
A3C6E2 recognizes human CD117, also known as c-kit or SCF receptor. It is a 145 kDa receptor tyrosine kinase that is involved in stem cell signaling, activation, and proliferation. The CD117 antigen is expressed on about 1–3% of mononuclear cells from peripheral blood mononuclear cells (PBMCs) or cord blood, and on up to 10% of bone marrow cells. CD117 is further expressed on basophils, myeloid dendritic cells, TCRa/b+ T cells, CD19+ B cells, and CD56+ NK cells, as well as on mast cells, melanocytes, and AML (acute myeloid leukemia) blasts.
Published
2021-03-26
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
04049934134432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049934134432040499341344324049934134432

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify002 - 8 °C Protected from light.

Sterilization Methods

Method

Contacts

PhoneEmail
800-367-6227technicalsupportUS@miltenyi.com

Regulatory Flags

DUNS number
342920388
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
040499341337257-AAD Staining Solution170-081-0882021-03-26
04049934133732CD45RA-FITC170-081-0862021-03-26
04049934133749Anti-TCRg/d-PE-Vio770170-081-0852021-03-26
04049934133756CD4-VioGreen (Clone REA623)170-081-0842021-03-26
04049934133763CD197-VioBlue170-081-0832021-03-26
04049934133770CD62L-PE-Vio770170-081-0822021-03-26
04049934133787CD62L-VioGreen170-081-0812021-03-26
04049934133794CD45RA-VioBlue170-081-0802021-03-26
04049934133800CD34-VioBlue170-081-0792021-03-26
04049934133817CD45-VioGreen (Clone REA747)170-081-0782021-03-26
04049934133824CD45-VioBlue (Clone REA747)170-081-0772021-03-26
04049934133831CD19-PE-Vio770170-081-0762021-03-26
04049934133848CD8-APC-Vio770 (Clone REA734)170-081-0752021-03-26
04049934133855CD20-PE-Vio770170-081-0742021-03-26
04049934133862CD8-APC-Vio770 (Clone BW135/80)170-081-0732021-03-26
04049934133879CD14-APC170-081-0722021-03-26
04049934133886Anti-TCRg/d-PE170-081-0712021-03-26
04049934133893Anti-TCRa/b-APC (Clone REA652)170-081-0702021-03-26
04049934133909Anti-TCRa/b-PE (Clone REA652)170-081-0692021-03-26
04049934133916CD38-APC (Clone REA671)170-081-0682021-03-26

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