BioPlex 2200 6651670G

GUDID 00847865002240

ToRC IgG Assay Protocol File CD, SW 4_v3

BIO-RAD LABORATORIES, INC.

Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Primary Device ID00847865002240
NIH Device Record Key0c41a82a-269c-47d4-81a0-ca3e337b73aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioPlex 2200
Version Model NumberSW4_V3
Catalog Number6651670G
Company DUNS884513334
Company NameBIO-RAD LABORATORIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100847865002240 [Primary]

FDA Product Code

OMIMultiplex flow immunoassay, t.Gondii, rubella and cmv.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-23
Device Publish Date2016-09-12

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00847865010993HSV-1 & HSV-2 Assay Protocol File CD, SW4.1_v2
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00847865010610Celiac IgA Control Set
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00847865003186Rubella & CMV Assay Protocol File CD, SW4_v3
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