AccessGUDID - DEVICE: CyFlow™ CD38 PE-Cy7 (08595715447766)

GUDID

Device Identifier (DI) Information

Brand Name: CyFlow™ CD38 PE-Cy7
Version or Model: AM704693
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AM704693
Company Name: EXBIO Praha, a.s.

Primary DI Number: 08595715447766
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 495024965 *Terms of Use

Device Description: The reagent may have application in various test methodologies, including Flow Cytometry. Vial has sufficient volume for 100 tests, if used at 10 uL / test. The reagent is provided in stabilizing phosphate buffered saline (PBS) solution, pH 7.4, containing 0.09% (w/v) sodium azide.

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?
56917	Multiple CD cell marker IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of multiple cluster of differentiation (CD) cell markers in a clinical specimen, including associated percentage and/or enumeration of specific cell populations.	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1 Milliliter

Device Record Status

Public Device Record Key: d00a4ade-3454-4bcc-b4f7-ce3e341a1b1d
Public Version Date: July 12, 2024
Public Version Number: 1
DI Record Publish Date: July 04, 2024