FDA.reportPublic FDA data

Rapid Response

Primary DI
00722066001905
Brand
Rapid Response
Company
BTNX Inc
Model
ADE-9C20
Catalog number
ADE-9C20
Device description
Rapid Response Adenovirus Test Cassettes - 20 tests/ kit are for the qualitative detection of various adenovirus in fecal samples.
Published
2016-10-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GODAntigens, Cf (Including Cf Control), Adenovirus 1-33

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GODAntigens, Cf (Including Cf Control), Adenovirus 1-33Microbiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990630000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990630000SAS ADENO TESTSa Scientific, Inc.1999-08-19GOD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00722066001905PrimaryGS10
00722066004296Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00722066001905007220660019057220660019050722066001905
00722066004296007220660042967220660042960722066004296

GMDN Terms#

Term, Definition table
TermDefinition
Adenovirus antigen IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Adenovirus in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
251005005
Device count
20
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10722066015053Rapid ResponseD12.49-1VAF2026-05-15
10722066015084Rapid ResponseD13.5-1VF2026-05-15
10722066011260Rapid ResponseD13.5-1VF2026-01-19
10722066011277Rapid ResponseD12.49-1VAF2026-01-19
20722066011267Rapid ResponseD13.5-1VF2026-01-19
20722066011274Rapid ResponseD12.49-1VAF2026-01-19
10722066011338Rapid ResponseFOB-9C36FOB-9C362026-01-02
20722066011335Rapid ResponseFOB-9C36FOB-9C362026-01-02
00722066000205Rapid ResponseHCG-3C50HCG-3C502016-10-25
00722066000267Rapid ResponseHCG-3C25HCG-3C252016-10-25
00722066004548Rapid ResponseD12.5-1V2019-01-21
10722066009083Rapid ResponseD12.49-1VA2025-10-03
10722066010973Rapid ResponseD13.5-1V2025-07-08
00722066010976Rapid ResponseD13.5-1V2025-07-08
10722066009601Rapid ResponseCOF-19CGHU22025-05-29
10722066009618Rapid ResponseCOF-19CGHU42025-05-29
10722066010751Rapid ResponseSTR-15SGPU-252025-05-29
10722066009595Rapid ResponseCOF-19CGHU12025-05-29
00722066009604Rapid ResponseCOF-19CGHU22025-05-29
00722066009611Rapid ResponseCOF-19CGHU42025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033891327606CHORUS ADENOVIRUS IgGDIESSE DIAGNOSTICA SENESE SPAGOD2024-01-22
04048474034462Adenovirus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGOD2023-08-29
00840239034465Adenovirus IgG ELISADRG International IncGOD2023-08-24
00404847434460Adenovirus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGOD2021-06-07
00840733101755PREMIER AdenocloneMERIDIAN BIOSCIENCE, INC.GOD2020-10-06
00840733101748PREMIER Adenoclone Type 40/41MERIDIAN BIOSCIENCE, INC.GOD2020-09-21
30014613336754InflammaDryQUIDEL CORPORATIONGOD2019-08-02
30014613336686AdenoPlusQUIDEL CORPORATIONGOD2018-11-10
04058863017792Quadrox-iMaquet Cardiopulmonary AGGOD2017-03-13