BioPlex 2200 6600000

GUDID 00847865002813

BioPlex 2200 Instrument

BIO-RAD LABORATORIES, INC.

Multiplex analyser IVD, laboratory, automated
Primary Device ID00847865002813
NIH Device Record Keydfe2023f-e5d0-4843-ade8-e4a4354e5fb8
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioPlex 2200
Version Model Number6600000
Catalog Number6600000
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 Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100847865002813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NSUInstrumentation for clinical multiplex test systems

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

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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