AccessGUDID - DEVICE: Quest Diagnostics (03610520540916)

GUDID

Device Identifier (DI) Information

Brand Name: Quest Diagnostics
Version or Model: 930
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 930
Company Name: BIO-RAD LABORATORIES, INC.

Primary DI Number: 03610520540916
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 051624070 *Terms of Use

Device Description: Quest Diagnostics Immunoassay/TDM Control (A human serum immunoassay/TDM control.)

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:	Yes
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?
53594	Multiple clinical chemistry protein IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry proteins in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJY	Multi-analyte controls, all kinds (assayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050536	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e61d424a-c4e7-48be-a45c-9d511f47f052
Public Version Date: October 17, 2023
Public Version Number: 1
DI Record Publish Date: October 09, 2023