AccessGUDID - DEVICE: Liquichek (00847661004622)

GUDID

Device Identifier (DI) Information

Brand Name: Liquichek
Version or Model: 289
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 289
Company Name: BIO-RAD LABORATORIES, INC.

Primary DI Number: 00847661004622
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 051624070 *Terms of Use

Device Description: Liquichek Homocysteine Control Level 3 (A human serum assayed homocysteine 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?
53750	Homocysteine 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 homocysteine in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	Single (specified) analyte controls (assayed and unassayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K984071	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: aeca0438-38b5-440d-87d9-f50d38852794
Public Version Date: August 20, 2024
Public Version Number: 6
DI Record Publish Date: January 09, 2017