AccessGUDID - DEVICE: CD197-VioBlue (04049934133763)

GUDID

Device Identifier (DI) Information

Brand Name: CD197-VioBlue
Version or Model: 170-081-083
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Miltenyi Biotec B.V. & Co. KG

Primary DI Number: 04049934133763
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 342920388 *Terms of Use

Device Description: REA546 recognizes the human CD197 antigen, which is also known as CCR7. CD197 is a chemokine receptor with a C-C motif that mediates homing of T cells to secondary lymphoid organs via high endothelial venules (HEV). For example, naive T cells migrate very efficiently through lymph nodes using the adhesion molecules L-selectin, CD62L, and CCR7. Ligands for CCR7, e.g. CCL19, are expressed by the HEV of secondary lymphoid organs, by parenchymal cells within T cell zones of lymph nodes, and by endothelial cells at the openings of lymphatic vessels within peripheral tissues. Expression of CCR7 and the CD45RA isoform distinguishes three subsets of T cells: naive T cells (CCR7+CD45RA+), central memory T cells (CCR7+ CD45RA-), and effector memory T cells (CCR7- CD45RA-). Additional information: Clone REA546 displays negligible binding to Fc receptors.

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: 2f3f9f4c-c25b-4036-a8de-9ef92b2328fc
Public Version Date: April 05, 2021
Public Version Number: 1
DI Record Publish Date: March 26, 2021