AccessGUDID - DEVICE: CD34-VioBlue (04049934133800)

GUDID

Device Identifier (DI) Information

Brand Name: CD34-VioBlue
Version or Model: 170-081-079
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Miltenyi Biotec B.V. & Co. KG

Primary DI Number: 04049934133800
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 342920388 *Terms of Use

Device Description: AC136 recognizes the human CD34, a class III epitope of the CD34 antigen. This epitope is different than the one recognized by the clone used in the CD34 MicroBead Kits. The CD34 antigen is a single-chain transmembrane glycoprotein, expressed on human hematopoietic stem and progenitor cells, endothelial progenitor cells, vascular endothelial cells, embryonic fibroblasts, and some cells in fetal and adult nervous tissue. The antigen is absent on fully differentiated hematopoietic cells, such as normal peripheral blood lymphocytes, monocytes, granulocytes, erythrocytes, and platelets. Clone AC136 has a similar specificity as the CD34 monoclonal antibody clone 8G12 (HPCA-2). CD34 antibodies can be used for studies of hematopoiesis and nonhematopoietic stem cells, phenotyping of hematopoietic stem cells, and studies on phenotyping of hematologic malignancies, endothelial cells, and endothelial progenitor cells (EPCs).

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: 3d443d4d-e84f-4888-8fe5-901570680ccf
Public Version Date: April 05, 2021
Public Version Number: 1
DI Record Publish Date: March 26, 2021