AccessGUDID - DEVICE: Mono Mo a Hu CD19/FITC + Poly Rb a Hu Lambda LC/RPE + Poly Rb a Hu Kappa LC/APC (05700572020165)

GUDID

Device Identifier (DI) Information

Brand Name: Mono Mo a Hu CD19/FITC + Poly Rb a Hu Lambda LC/RPE + Poly Rb a Hu Kappa LC/APC
Version or Model: TC669
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: AGILENT TECHNOLOGIES SINGAPORE PTE LTD

Primary DI Number: 05700572020165
Issuing Agency: GS1
Commercial Distribution End Date: August 04, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 894671143 *Terms of Use

Device Description: MultiMix Triple-Colour Reagent Anti-Human CD19/FITC Anti-Human Lambda Light Chains/RPE Anti-Human Kappa Light Chains/APC

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
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1 Milliliter

Device Record Status

Public Device Record Key: 476c5716-37f7-459f-9e3d-c6f4c2d53f3b
Public Version Date: December 07, 2020
Public Version Number: 2
DI Record Publish Date: August 04, 2020