AccessGUDID - DEVICE: BioPlex 2200 (00847865002721)

GUDID

Device Identifier (DI) Information

Brand Name: BioPlex 2200
Version or Model: SW4_V2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6651160G
Company Name: BIO-RAD LABORATORIES, INC.

Primary DI Number: 00847865002721
Issuing Agency: GS1
Commercial Distribution End Date: September 13, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 884513334 *Terms of Use

Device Description: Manual & CDs, ANA Screen with MDSS IFU, SW 4_v2

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:	No
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?
54810	Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for multiple types of antinuclear antibodies (ANA) in a clinical specimen, using a multiplex method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LKJ	ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL
LJM	ANTINUCLEAR ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROLS
LRM	ANTI-DNA ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROL
LKO	ANTI-RNP ANTIBODY, ANTIGEN AND CONTROL
LLL	EXTRACTABLE ANTINUCLEAR ANTIBODY, ANTIGEN AND CONTROL
MQA	ANTI-RIBOSOMAL P ANTIBODIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1 Each

Device Record Status

Public Device Record Key: 53556e72-f98c-4331-8b5e-e34578aa9100
Public Version Date: November 07, 2019
Public Version Number: 3
DI Record Publish Date: September 12, 2016