FDA.reportPublic FDA data

AccuDiag ™

Primary DI
00894175000138
Brand
AccuDiag ™
Company
Diagnostic Automation, Inc.
Model
DACD8202-35
Catalog number
8202-35
Device description
AccuDiag™ Echinococcus IgG ELISA
Published
2024-03-27
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
GPFAntigen, Agglutinating, Echinococcus Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GPFAntigen, Agglutinating, Echinococcus Spp.Microbiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00894175000138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894175000138008941750001388941750001380894175000138

GMDN Terms#

Term, Definition table
TermDefinition
Echinococcus granulosus 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 Echinococcus granulosus in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Echinococcus granulosus, the parasitic tapeworm associated with hydatid disease.

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
8185913030Onestep@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
ENTIECHG01300NovaLisa Echinococcus IgGGold Standard Diagnostics Frankfurt GmbHGPF2024-08-26
ENTIECHG0130NovaLisa Echinococcus IgGGold Standard Diagnostics Frankfurt GmbHGPF2024-08-26
08033891320010CHORUS ECHINOCOCCUS IgGDIESSE DIAGNOSTICA SENESE SPAGPF2024-01-22
04048474034721Echinococcus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGPF2023-08-29
00840239034724Echinococcus IgG ELISADRG International IncGPF2023-08-24
B350GSD0130030Echinococcus IgG ELISA Test KitGold Standard Diagnostics CorporationGPF2022-12-07
07640158219317Echinococcus multilocularis (Em18) IgG ELISA Bordier affinity products S.A.GPF2022-08-17
07640158219300Echinococcus multilocularis (Em2-Em18) IgG ELISA Bordier affinity products S.A.GPF2022-08-09
07640158219355Echinococcus granulosus IgG ELISABordier affinity products S.A.GPF2022-08-09
00404847434729Echinococcus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGPF2021-06-07
B24220EGGHUE010Echinococcus Granulosus IgG ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.GPF2020-09-25