FDA.reportPublic FDA data

Bio-Rad Laboratories, Inc.

Primary DI
00847865010757
Brand
Bio-Rad Laboratories, Inc.
Company
Bio-RAD Laboratories, Inc.
Model
25180
Catalog number
25180
Device description
VZV IgG EIA
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFYENZYME LINKED IMMUNOABSORBENT ASSAY, VARICELLA-ZOSTER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFYEnzyme Linked Immunoabsorbent Assay, Varicella-ZosterMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972295000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972295000SERAQUEST VZV IGGQuest Intl., Inc.1997-11-05LFY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847865010757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847865010757008478650107578478650107570847865010757

GMDN Terms#

Term, Definition table
TermDefinition
Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to varicella-zoster virus (VZV) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)224-6723TechSupport.USSD-Redmond@bio-rad.com

Regulatory Flags#

DUNS number
844766394
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847661000778Lyphochek7447442016-09-12
00847661000785Lyphochek7457452016-09-12
00847661000792Lyphochek7467462016-09-12
00847661001027Lyphochek5975972016-09-12
00847661001034Lyphochek5985982016-09-12
00847661001041Lyphochek5995992016-09-12
00847661001898Lyphochek598X598X2016-09-12
00847661001959Lyphochek745X745X2016-09-12
0361052031061896AN96AN-BPU-QUEST96AN-BPU-QUEST2016-09-12
03610520547663ANA PLATE196AN-BPU196AN-BPU2016-09-12
0361052056045796AN96AN-BPU-TRINITY96AN-BPU-TRINITY2016-09-12
03610520569184ANA PLATE196AN-BPU-ED196AN-BPU-ED2016-09-12
00847661000082Liquichek1071072016-09-12
00847661000099Liquichek1081082016-09-12
00847661000105Liquichek1111112016-09-12
00847661000112Liquichek1121122016-09-12
00847661000129Liquichek1181182016-09-12
00847661000204Liquichek1291292016-09-12
00847661000211Liquichek1311312016-09-19
00847661000228Liquichek1301302016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03573026644796VIDAS® Varicella-Zoster IgGBIOMERIEUX SALFY2026-01-19
04048474028089Varicella Zoster Virus (VZV) IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLFY2023-08-29
00840239028082Varicella Zoster Virus (VZV) IgG ELISA DRG International IncLFY2023-08-24
B3507203800Gold Standard Diagnostics Is-VZV IgG ELISA Test KitGold Standard Diagnostics CorporationLFY2020-05-20
05391516746755Trinity BiotechCLARK LABORATORIES, INC.LFY2019-12-26
05391516746793Trinity BiotechCLARK LABORATORIES, INC.LFY2019-12-26
05391516746830Trinity BiotechCLARK LABORATORIES, INC.LFY2019-12-26
05391516743532Trinity BiotechCLARK LABORATORIES, INC.LFY2016-09-23
00817273020228DiamedixDIAMEDIX CORPORATIONLFY2016-09-20
00847865000727BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865000734BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865000741BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865000758BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865000765BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865002189BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865002264BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865002332BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865010979BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
03573026064518VIDAS® Varicella-Zoster IgGBIOMERIEUX SALFY2016-08-31
00850487007012ReQuestQUEST INTERNATIONAL, INC.LFY2016-08-31
00850487007340SeraQuestQUEST INTERNATIONAL, INC.LFY2016-08-31
00816057020584ASI VZV IgG EIA TestARLINGTON SCIENTIFIC, INC.LFY2016-07-08