AccessGUDID - DEVICE: Poly Rb A-Hu IgA, IgG, IgM, Kappa, Lambda/HRP (05700572007319)

GUDID

Device Identifier (DI) Information

Brand Name: Poly Rb A-Hu IgA, IgG, IgM, Kappa, Lambda/HRP
Version or Model: P0212
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AGILENT TECHNOLOGIES SINGAPORE PTE LTD

Primary DI Number: 05700572007319
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 894671143 *Terms of Use

Device Description: Polyclonal Rabbit Anti-Human IgA, IgG, IgM, Kappa, Lambda/HRP

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?
57325	Kappa/lambda light chain immunoglobulin 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 kappa and/or lambda light chain immunoglobulins in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DEP	LAMBDA, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL
CZL	IGA, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL
DAA	IGG, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL
DEY	IGM, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL
DFD	Kappa, Peroxidase, Antigen, Antiserum, Control

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: 2 Milliliter

Device Record Status

Public Device Record Key: 3cac21aa-b76c-4042-bbb8-51cd47b7eea2
Public Version Date: December 07, 2020
Public Version Number: 6
DI Record Publish Date: September 16, 2016