AccessGUDID - DEVICE: Negative Control Mo IgG1/RPE, Cl DAK-GO1 (05700572028482)

GUDID

Device Identifier (DI) Information

Brand Name: Negative Control Mo IgG1/RPE, Cl DAK-GO1
Version or Model: X0928
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AGILENT TECHNOLOGIES SINGAPORE PTE LTD

Primary DI Number: 05700572028482
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 894671143 *Terms of Use

Device Description: Negative Control Mouse IgG1/RPE, Clone DAK-GO1

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?
41353	Total immunoglobulin G (IgG total) IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total immunoglobulin G (IgG total) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GKZ	Counter, differential cell

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: Keep away from sunlight
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: ce646e28-d7f8-4361-90d5-1a6fbd42f34c
Public Version Date: December 07, 2020
Public Version Number: 8
DI Record Publish Date: September 16, 2016