FDA.reportPublic FDA data

AccuDiag ™

Primary DI
00894175000114
Brand
AccuDiag ™
Company
Diagnostic Automation, Inc.
Model
DACD8209-35
Catalog number
8209-35
Device description
AccuDiag™ Schistosoma IgG ELISA - For the qualitative detection of immunoglobulin G (IgG) antibodies to multiple species of the parasitic flatworm Schistosoma in a clinical specimen, using an enzyme immunoassay (EIA) method.
Published
2024-03-06
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
GNHAntigen, Fluorescent Antibody Test, Schistosoma Mansoni

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GNHAntigen, Fluorescent Antibody Test, Schistosoma MansoniMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00894175000114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894175000114008941750001148941750001140894175000114

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Schistosoma species 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 multiple species of the parasitic flatworm Schistosoma 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
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
ENTISCHG04100NovaLisa Schistosoma mansoni IgGGold Standard Diagnostics Frankfurt GmbHGNH2024-08-26
ENTISCHG0410NovaLisa Schistosoma mansoni IgGGold Standard Diagnostics Frankfurt GmbHGNH2024-08-26
04048474038729Schistosoma mansoni IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGNH2023-08-31
04048474035124Schistosoma IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGNH2023-08-29
00840239038722Schistosoma mansoni IgG ELISADRG International IncGNH2023-08-25
04049016135449Anti-Schistosoma ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNH2022-12-08
07640158219607Schistosoma mansoni IgG ELISABordier affinity products S.A.GNH2022-08-09
00840239035127Schistosoma IgG ELISADRG International IncGNH2021-06-07
04049016101727Anti-Schistosoma mansoni IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNH2016-09-24
00813545026455Schistosoma Antibody 96 Tests SCIMEDX CORPORATIONGNH2016-09-21