AccessGUDID - DEVICE: CD117-PE (04049934134449)

GUDID

Device Identifier (DI) Information

Brand Name: CD117-PE
Version or Model: 170-081-015
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Miltenyi Biotec B.V. & Co. KG

Primary DI Number: 04049934134449
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 342920388 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64705	Assay development analyte-specific reagent IVD	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVU	Reagents, Specific, Analyte

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: 2 - 8 °C Protected from light.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0813135d-53c9-45cb-8abe-958d772f101e
Public Version Date: April 05, 2021
Public Version Number: 1
DI Record Publish Date: March 26, 2021