AccessGUDID - DEVICE: Bio-Rad Laboratories, Inc. (00847865011150)

GUDID

Device Identifier (DI) Information

Brand Name: Bio-Rad Laboratories, Inc.
Version or Model: 25188
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 25188
Company Name: Bio-RAD Laboratories, Inc.

Primary DI Number: 00847865011150
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 844766394 *Terms of Use

Device Description: Diluent for Rubella IgM, CMV IgM and VCA IgM 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?
58208	Buffered sample diluent IVD, manual	A buffered solution intended to be used for the manual (non-automated) dilution of samples, either pre-analytically or during the processing, staining and/or testing of clinical laboratory specimens.	Obsolete	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K982485	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
Device Size Text, specify: 96 Tests

Device Record Status

Public Device Record Key: c3db3792-db01-41d2-87ac-5e72f2291c48
Public Version Date: January 31, 2023
Public Version Number: 6
DI Record Publish Date: September 12, 2016