FDA.reportPublic FDA data

AccuDiag ™

Primary DI
00850049545235
Brand
AccuDiag ™
Company
Diagnostic Automation, Inc.
Model
DACD1506-12
Catalog number
1506-12
Device description
AccuDiag ™ H. pylori Antigen ELISAIntended to be used for the qualitative and/or quantitative detection of antigens from Helicobacter pylori bacteria in a clinical specimen, using an enzyme immunoassay (EIA) method.
Published
2024-05-23
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
LYRHelicobacter Pylori

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYRHelicobacter PyloriMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850049545235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850049545235008500495452358500495452350850049545235

GMDN Terms#

Term, Definition table
TermDefinition
Helicobacter pylori antigen 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 antigens from Helicobacter pylori bacteria 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
10763924750044Accutest H. Pylori Urease Rapid Test JANT PHARMACAL CORPORATIONLYR2026-04-21
10673486013986Teco Diagnostics H. Pylori Card TestTECO DIAGNOSTICSLYR2026-01-27
00816576028481 QwikIDHARDY DIAGNOSTICSLYR2025-06-23
00816576027439 QwikIDHARDY DIAGNOSTICSLYR2025-06-23
00860001810394PyloPlus+ Rapid Urease TestArj Medical, Inc.LYR2025-01-29
20888277717777MEDLINEMEDLINE INDUSTRIES, INC.LYR2024-08-08
10888277717770MEDLINEMEDLINE INDUSTRIES, INC.LYR2024-08-08
00628451188278MedMira Rapid H. Pylori Antibody TestMedMira Laboratories IncLYR2024-07-09
10673486002393Teco Diagnostics H. pylori Card TestTECO DIAGNOSTICSLYR2024-01-16
00083059070835Hp Detect Stool Antigen ELISABIOMERICA, INC.LYR2024-01-08
04048474028157H. Pylori IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLYR2023-08-29
00840733101472Premier HpSA FlexMERIDIAN BIOSCIENCE, INC.LYR2023-08-28
00840239028150H. Pylori IgG ELISA DRG International IncLYR2023-08-24
00612479261471McKessonMCKESSON MEDICAL-SURGICAL INC.LYR2023-05-23
00612479261501McKessonMCKESSON MEDICAL-SURGICAL INC.LYR2023-05-23
00612479261488McKessonMCKESSON MEDICAL-SURGICAL INC.LYR2023-05-23
00612479261518McKessonMCKESSON MEDICAL-SURGICAL INC.LYR2023-05-23
00848838022012REMELREMEL, INC.LYR2022-12-22
20885380183642CARDINAL HEALTHCardinal Health 200, LLCLYR2022-02-23
10885380183645CARDINAL HEALTHCardinal Health 200, LLCLYR2022-02-23
10304040155742Henry ScheinHENRY SCHEIN, INC.LYR2021-10-14
00304040155745Henry ScheinHENRY SCHEIN, INC.LYR2021-10-14
10743816001584Status™ H. pylori cardPRINCETON BIOMEDITECH CORPORATIONLYR2021-08-04
10743816001591Status™ H. pylori cardPRINCETON BIOMEDITECH CORPORATIONLYR2021-08-04
00893029002502HpOneGI Supply, Inc.LYR2021-07-08
00893029002519HpFastGI Supply, Inc.LYR2021-07-08
00893029002571UreaseGI Supply, Inc.LYR2021-07-08
00857031002639H. PYLORI CHEK TECHLAB, INC.LYR2021-03-12
00840733101731PREMIER H. pyloriMERIDIAN BIOSCIENCE, INC.LYR2020-09-01
00840733101670PREMIER Platinum HpSA PLUSMERIDIAN BIOSCIENCE, INC.LYR2020-08-11