AccessGUDID - DEVICE: BioPlex 2200 (00847865001137)

GUDID

Device Identifier (DI) Information

Brand Name: BioPlex 2200
Version or Model: 6633800
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6633800
Company Name: BIO-RAD LABORATORIES, INC.

Primary DI Number: 00847865001137
Issuing Agency: GS1
Commercial Distribution End Date: July 06, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 884513334 *Terms of Use

Device Description: Rubella & CMV IgM Calibrator Set

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:	Yes
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?
49727	Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to cytomegalovirus (CMV) in a clinical specimen.	Active	false
50270	Rubella virus immunoglobulin M (IgM) antibody 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 immunoglobulin M (IgM) antibodies to Rubella virus in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE

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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 3 Vials
Total Volume: 0.5 Milliliter

Device Record Status

Public Device Record Key: bb307869-1ef8-405e-9dcb-f6aa2583aac9
Public Version Date: July 29, 2021
Public Version Number: 7
DI Record Publish Date: September 12, 2016