FDA.reportPublic FDA data

Bio-Rad Laboratories

Primary DI
00847865010764
Brand
Bio-Rad Laboratories
Company
Bio-RAD Laboratories, Inc.
Model
25181
Catalog number
25181
Device description
Measles IgG EIA
Published
2023-01-22
Public version status
New
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
LJBEnzyme linked immunoabsorbent assay, rubeola IgG

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJBEnzyme Linked Immunoabsorbent Assay, Rubeola IggMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847865010764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847865010764008478650107648478650107640847865010764

GMDN Terms#

Term, Definition table
TermDefinition
Measles virus 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 Measles virus 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

Contacts#

Phone, Email table
PhoneEmail
+1(800)224-6723techsupport.ussd-redmond@bio-rad.com

Regulatory Flags#

DUNS number
844766394
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
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
00850054026156QMedix™Diagnostic Automation, Inc.LJB2025-06-05
ENTIMEAG03300NovaLisa Measles Virus IgGGold Standard Diagnostics Frankfurt GmbHLJB2024-08-26
ENTIMEAG0330NovaLisa Measles Virus IgGGold Standard Diagnostics Frankfurt GmbHLJB2024-08-26
08033891322434CHORUS MEASLES IgGDIESSE DIAGNOSTICA SENESE SPALJB2024-01-22
04048474059670Measles Virus IgG Avidity ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJB2023-09-01
00840239059673Measles Virus IgG Avidity ELISADRG International IncLJB2023-08-26
00850049545396AccuDiag ™Diagnostic Automation, Inc.LJB2023-06-14
00404847459678Measles Virus IgG Avidity ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJB2021-06-07
B3507205200Gold Standard Diagnostics Is-Measles IgG ELISA Test KitGold Standard Diagnostics CorporationLJB2020-05-20
05391516743631Trinity BiotechCLARK LABORATORIES, INC.LJB2019-10-25
05391516747127Trinity BiotechCLARK LABORATORIES, INC.LJB2019-10-25
03573026064532VIDAS® Measles IgGBIOMERIEUX SALJB2019-08-30
04048474038446Measles Virus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJB2019-06-05
00404847438444Measles Virus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJB2019-06-05
00840239038449Measles Virus IgG ELISADRG International IncLJB2019-03-20
04049016027973Anti-Measles Virus ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLJB2016-09-24
04049016083276Avidity: Anti-Measles Virus ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLJB2016-09-24
00817273020303DiamedixDIAMEDIX CORPORATIONLJB2016-09-20
00847865000727BioPlex 2200BIO-RAD LABORATORIES, INC.LJB2016-09-12
00847865000734BioPlex 2200BIO-RAD LABORATORIES, INC.LJB2016-09-12
00847865000741BioPlex 2200BIO-RAD LABORATORIES, INC.LJB2016-09-12
00847865000758BioPlex 2200BIO-RAD LABORATORIES, INC.LJB2016-09-12
00847865000765BioPlex 2200BIO-RAD LABORATORIES, INC.LJB2016-09-12
00847865002189BioPlex 2200BIO-RAD LABORATORIES, INC.LJB2016-09-12
00847865002264BioPlex 2200BIO-RAD LABORATORIES, INC.LJB2016-09-12
00847865002332BioPlex 2200BIO-RAD LABORATORIES, INC.LJB2016-09-12
00847865010979BioPlex 2200BIO-RAD LABORATORIES, INC.LJB2016-09-12
00850487007104ReQuest QUEST INTERNATIONAL, INC.LJB2016-08-31
00850487007111ReQuestQUEST INTERNATIONAL, INC.LJB2016-08-31
00850487007357SeraQuestQUEST INTERNATIONAL, INC.LJB2016-08-31