AccessGUDID - DEVICE: FLEX Negative Control Rb Immunoglobulin RTU (05700571101902)

GUDID

Device Identifier (DI) Information

Brand Name: FLEX Negative Control Rb Immunoglobulin RTU
Version or Model: IS600
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: AGILENT TECHNOLOGIES, INC.

Primary DI Number: 05700571101902
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 084963177 *Terms of Use

Device Description: FLEX Negative Control Rabbit Immunoglobulin fraction of serum from non-immunized rabbits, solid phase absorbed Ready-to-Use (Dako Autostainer/ Autostainer Plus)

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?
57776	Negative control immunoglobulin IVD	A material containing immunoglobulin intended to be used in place of a primary antibody as a negative control to verify the performance of an assay that utilizes antibodies (e.g., immunoassay, immunohistochemistry or flow cytometry) and is performed on biological tissues or clinical specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NJT	IMMUNOHISTOCHEMISTRY REAGENTS AND KITS

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
Device Size Text, specify: 40-60 Tests

Device Record Status

Public Device Record Key: a11fd965-a464-4a9c-a52a-db144742ab79
Public Version Date: August 16, 2023
Public Version Number: 3
DI Record Publish Date: September 17, 2020