Bio-Rad Laboratories, Inc. 25180

GUDID 00847865010757

VZV IgG EIA

Bio-RAD Laboratories, Inc.

Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00847865010757
NIH Device Record Key59a23743-22eb-4907-b191-6e5a231595c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameBio-Rad Laboratories, Inc.
Version Model Number25180
Catalog Number25180
Company DUNS844766394
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 Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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-Redmond@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD-Redmond@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD-Redmond@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD-Redmond@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD-Redmond@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD-Redmond@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD-Redmond@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD-Redmond@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 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100847865010757 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFYENZYME LINKED IMMUNOABSORBENT ASSAY, VARICELLA-ZOSTER

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 [Bio-Rad Laboratories, Inc.]

00847865019354Slide Blotters, 24-well
00847865019347Slide Blotters, 8-well
00847865019330Slide Blotters, 4-well
00847865017343Slide Blotters, 6-well
00847865017244Slide Blotters, 12-well
00847865011495Anti-Borrelia (Lyme) EIA, Conjugate
00847865011488Anti-Borrelia (Lyme) EIA, Borrelia Blocker
00847865011471Anti-Borrelia (Lyme) EIA, Positive Control
00847865011464Anti-Borrelia (Lyme) EIA, Negative Control
00847865011457Anti-Borrelia (Lyme) EIA Calibrator
00847865011280Anti-Borrelia (Lyme) EIA, Stop Solution
00847865011273Anti-Borrelia (Lyme) EIA , Substrate Concentrate
00847865011266Anti-Borrelia (Lyme) EIA, Substrate Buffer
00847865011259Anti-Borrelia (Lyme) EIA, Wash Buffer Concentrate [20X]
00847865011198Substrate for Serology EIA Tests
00847865011181Stop Reagent for Serology EIA Tests
00847865011174Wash Concentrate for Serology EIA Tests
00847865011150Diluent for Rubella IgM, CMV IgM and VCA IgM EIA Tests
00847865011136Diluent for Rubella, Toxo, CMV, HSV, VZV, Measles, Mumps, EBNA and EB EAD IgG EIA Tests
00847865010757VZV IgG EIA
00847865010740HSV IgG EIA
00847865010733CMV IgM EIA
00847865010726CMV IgG EIA
00847865010702Toxoplasma IgG EIA
00847865010696Rubella IgM EIA
00847865010689Rubella IgG EIA
00847865001731PBS For Immunofluorescent Assays, 11.34 gm
00847865001274Anti-Borrelia (Lyme) Microplate EIA
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