FDA.reportPublic FDA data

Rapid Response

Primary DI
00722066001899
Brand
Rapid Response
Company
BTNX Inc
Model
ROT-9C20
Catalog number
ROT-9C20
Device description
Rapid Response Rotavirus Test Cassettes - 20 tests/ kit are for qualitative detection of rotavirus antigens in fecal specimens.
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
LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIQEnzyme Linked Immunoabsorbent Assay, RotavirusMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990842000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990842000SAS ROTA TESTSa Scientific, Inc.1999-08-09LIQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00722066001899PrimaryGS10
00722066004289Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00722066001899007220660018997220660018990722066001899
00722066004289007220660042897220660042890722066004289

GMDN Terms#

Term, Definition table
TermDefinition
Rotavirus 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 Rotavirus 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
00840733101700PREMIER RotacloneMERIDIAN BIOSCIENCE, INC.LIQ2020-09-01
00840733101809ImmunoCard STAT! RotavirusMERIDIAN BIOSCIENCE, INC.LIQ2020-08-11