AccessGUDID - DEVICE: Bio-Rad Laboratories, Inc. (00847865011198)

GUDID

Device Identifier (DI) Information

Brand Name: Bio-Rad Laboratories, Inc.
Version or Model: 25192
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 25192
Company Name: Bio-RAD Laboratories, Inc.

Primary DI Number: 00847865011198
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 844766394 *Terms of Use

Device Description: Substrate for Serology EIA Tests

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?
55776	Organic solvent metabolite IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple metabolites/biomarkers (e.g., phenol) associated with occupational or environmental exposure to volatile organic solvents [e.g., benzene, styrene, toluene, xylene] in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LFZ	ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K954191	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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 12 Milliliter

Device Record Status

Public Device Record Key: 15393c70-9822-46bb-8a2d-f4cbaa85a26d
Public Version Date: January 31, 2023
Public Version Number: 7
DI Record Publish Date: September 12, 2016