BioPlex 2200 12001443

GUDID 03610520563922

U.S.IFU, Manual & CDs, BioPlex 2200 HIV Ag-Ab IFU, US, SW4.3_v5 12001443

BIO-RAD LABORATORIES, INC.

Laboratory instrument/analyser application software IVD
Primary Device ID03610520563922
NIH Device Record Key5ba14221-437e-46e0-b3f6-2723de1773c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioPlex 2200
Version Model Number4.3_v5
Catalog Number12001443
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
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
GS103610520563922 [Primary]

FDA Product Code

MZFTest, Hiv Detection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-03-22
Device Publish Date2016-02-29

On-Brand Devices [BioPlex 2200]

00847865013017Manual & CDs, Celiac IgA and IgG IFU, SW4.1_v1
00847865012997Manual & CDs, APLS IgA IFU, SW4.1_v1, US Only
00847865012980Manual & CDs, APLS IgM IFU, SW4.1_v1
00847865012973APLS IgG, IgM and IgA Assay Protocol File CD, SW4.1_v1 US Only
00847865012966Manual & CDs, APLS IgG IFU, SW4.1_v1, US Only
00847865012614Manual & CDs, EBV IgG IFU, SW4.1v1
00847865012607EBV IgG Assay Protocol File CD, SW4.1_v1, US
00847865012577Manual & CDs, Rubella & CMV IgM IFU, SW4.1_v1, U.S Only
00847865012522Manual & CDs, BioPlex 2200 APLS IgG IFU, SW4_v1, US Only
00847865012515Manual & CDs, APLS IgM IFU, SW4_v1, US Only
00847865012508APLS IgG, IgM and IgA Assay Protocol File CD, SW4_v1
00847865012331ANA Screen with MDSS Assay Protocol File CD, SW4.1_v2
0084786501165525-OH Vitamin D Reagent Pack
0084786501164825-OH Vitamin D Control Lot Data
0084786501163125-OH Vitamin D Control Set
0084786501162425-OH Vitamin D Lot Data
0084786501161725-OH Vitamin D Calibrator Set
00847865011358Manual & CDs, EBV IgM IFU, SW4_v2
00847865011341Manual & CDs, EBV IgM IFU, SW4.1_v1
00847865011129Manual & CDs, Celiac IgA and IgG IFU, SW4_v1
00847865011082Manual & CDs, Vasculitis IFU, SW4.1_v1
00847865011075U.S. IFU, Manual & CDs, ToRC IgG IFU, SW4.1_v1
00847865011006Rubella & CMV IgM Assay Protocol File CD, SW4.1_v1
00847865010993HSV-1 & HSV-2 Assay Protocol File CD, SW4.1_v2
00847865010986BioPlex 2200 Anti-CCP Assay Protocol File CD, SW4.1_v1
00847865010979MMRV IgG Assay Protocol File CD, SW4.1_v1
00847865010962Celiac IgG Assay Protocol File CD, SW4.1_v1
00847865010955Vasculitis Assay Protocol File CD, SW4.1_v1
00847865010948ToRC IgG Assay Protocol File CD, SW4.1_v1
00847865010924Syphilis IgG Assay Protocol File CD, SW4.1_v1
00847865010917Celiac IgG Calibrator Lot Data
00847865010900Celiac IgA Calibrator Lot Data
00847865010894Celiac IgG Control Lot Data
00847865010887Celiac IgA Control Lot Data
00847865010863Celiac IgG Reagent Pack
00847865010856Celiac IgA Reagent Pack
00847865010627Celiac IgG Control Set
00847865010610Celiac IgA Control Set
00847865010603Celiac IgG Calibrator Set,
00847865010597Celiac IgA Calibrator Set
00847865010580Celiac IgA Assay Protocol File CD, SW4_v1
00847865010573Celiac IgG Assay Protocol file CD, SW4_v1
00847865006682Manual & CDs, Syphilis IgG IFU, SW4.1_v1
00847865004725Manual & CDs, HSV-1 & HSV-2 IgG IFU, SW4_v2
00847865003186Rubella & CMV Assay Protocol File CD, SW4_v3
00847865003179Manual & CDs, Rubella & CMV IgM IFU, SW4_v3, US Only
00847865002998Manual & CDs, APLS IgA IFU, SW4_v1, US Only
00847865002820BPX2200, Analyzer System, Refurbishment
00847865002813BioPlex 2200 Instrument
00847865002721Manual & CDs, ANA Screen with MDSS IFU, SW 4_v2
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