AccessGUDID - DEVICE: CD203c-PE (04049934134241)

GUDID

Device Identifier (DI) Information

Brand Name: CD203c-PE
Version or Model: 170-081-035
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Miltenyi Biotec B.V. & Co. KG

Primary DI Number: 04049934134241
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 342920388 *Terms of Use

Device Description: Clone FR3-16A11 recognizes CD203c, a glycosylated type II transmembrane molecule that belongs to the family of ecto-nucleotide pyrophosphatase/ phosphodiesterase (E-NPP3) enzymes. Among hematopoietic cells, expression of CD203c is restricted to basophils as well as to mast cells and their precursors, and has been described as specific for this lineage. Protein and/or mRNA expression of CD203c has also been found in solid tissues such as uterus or prostate. Basophils and mast cells are key producers of mediators that drive the onset of inflammatory responses, e.g., in allergy. Allergen challenge leads to a rapid up-regulation of activation markers such as CD203c or CD63. Due to its restricted expression pattern, CD203c is discussed as a specific marker to monitor the allergen-induced activation of basophils, e.g., in flow cytometric basophil activation tests of the peripheral blood.

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: 6f971731-857a-4c94-8fc7-c21498e2c719
Public Version Date: April 05, 2021
Public Version Number: 1
DI Record Publish Date: March 26, 2021