AccessGUDID - DEVICE: Bio-Rad Laboratories, Inc. (00847865011174)

GUDID

Device Identifier (DI) Information

Brand Name: Bio-Rad Laboratories, Inc.
Version or Model: 25190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 25190
Company Name: Bio-RAD Laboratories, Inc.

Primary DI Number: 00847865011174
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 844766394 *Terms of Use

Device Description: Wash Concentrate 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?
58207	Buffered wash solution IVD, manual	A buffered wash solution intended to be used in combination with other IVDs during the manual processing, staining and/or testing of clinical laboratory specimens to neutralize/wash/rinse away excess reactants and/or to function as a wetting agent.	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 [?]
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: 30 Milliliter

Device Record Status

Public Device Record Key: 41cb8523-6153-4fa7-a047-1f68f7a95fc8
Public Version Date: January 31, 2023
Public Version Number: 6
DI Record Publish Date: September 12, 2016