FDA.reportPublic FDA data

AccuDiag ™

Primary DI
00850049545396
Brand
AccuDiag ™
Company
Diagnostic Automation, Inc.
Model
DACD1408-1
Catalog number
1408-1
Device description
AccuDiag ™Measles IgG Enzyme-Linked Immu-nosorbent Assay (ELISA) is intended for the detection and quantitative determination of IgG antibodies to Measles (Rubeola) virus in human sera.
Published
2023-06-14
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
00850049545396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850049545396008500495453968500495453960850049545396

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
818-591-3030Onestep@rapidtest.com

Regulatory Flags#

DUNS number
878252071
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
00850054026446AccuDiag™ T3 ELISA KitDACD3144-153144-152026-03-02
00850082766024AccuDiag™ Mycoplasma pneumoniae IgG ELISADACD8042-28042-22026-03-02
00894175000725AccuDiag™ ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ELISA DACD2506-22506-22026-02-27
00850049545433AccuDiag™ Prolactin (PRL) ELISADACD4226-154226-152026-01-30
00850054026712AccuDiag™ LH ELISADACD4225-154225-152026-01-30
00894175000800AccuDiag™ Progesterone ELISADACD2077-152077-152026-01-30
00850054026569QMedix™DACD5102-25102-22024-04-23
00850049545723AccuDiag™ Insulin ELISADACD1606-151606-152026-01-27
00850049545815AccuDiag™ Human Growth Hormone (HGH) ELISADACD1901-151901-152026-01-27
00850054026255AccuDiag™ C-Peptide ELISA KitDACD1293-151293-152026-01-27
00850054026682AccuDiag™ Estradiol ELISA DACD2046-152046-152026-01-27
00850054026705 AccuDiag™ FSH ELISADACD4224-154224-152026-01-27
00850082766017AccuDiag™ Free Estriol ELISA DACD3171-153171-152026-01-27
00894175000770AccuDiag™ 17-alpha-OH Progesterone ELISADACD1292-151292-152026-01-27
00894175000824AccuDiag™ ANST (Androstenedione) ELISADACD1038-151038-152026-01-27
10850049545492QMedix™DACD104110-1-19104110-1-192025-12-24
10850082766007QMedix™DACD113030-1-19113030-1-192025-12-24
00850049545501Diagnostic Automation, Inc.DAI SF2100SF21002025-12-24
00850054026392Diagnostic Automation, Inc.DAI SF2600SF26002025-12-24
00850049545495QMedix™DACD104110-1-19104110-1-192025-12-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049016158547Anti-Measles Virus ELISA 2.0 (IgG)EUROIMMUN Medizinische Labordiagnostika AGLJB2026-05-29
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
00847865010764Bio-Rad LaboratoriesBio-RAD Laboratories, Inc.LJB2023-01-22
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