AccessGUDID - DEVICE: Liquichek (00847661001348)

GUDID

Device Identifier (DI) Information

Brand Name: Liquichek
Version or Model: 725
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 725
Company Name: BIO-RAD LABORATORIES, INC.

Primary DI Number: 00847661001348
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 051624070 *Terms of Use

Device Description: Liquichek Therapeutic Drug Monitoring Control (TDM) Level 1 (A human serum assayed 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?
55235	Multiple-therapy therapeutic drug monitoring IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DIF	Drug mixture control materials

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K012741	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
Storage Environment Temperature: between -70 and -20 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f2d758b7-a17d-451d-bf28-e7953a7d2198
Public Version Date: January 31, 2023
Public Version Number: 2
DI Record Publish Date: September 14, 2020