FDA.reportPublic FDA data

ID NOW RSV Control Swab Kit

Primary DI
10811877010538
Brand
ID NOW RSV Control Swab Kit
Company
Alere Scarborough, Inc.
Model
435-080
Device description
Control Swabs intended for use only with the ID NOW RSV product.
Published
2018-10-29
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
OCCRespiratory Virus Panel Nucleic Acid Assay System
OEMHuman Metapneumovirus (Hmpv) Rna Assay System
OOIReal Time Nucleic Acid Amplification System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCCRespiratory Virus Panel Nucleic Acid Assay SystemMicrobiology2
OEMHuman Metapneumovirus (Hmpv) Rna Assay SystemMicrobiology2
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161375000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161375000Alere i RSV, Alere i Instrument, Alere i RSV Control Swab KitAlere Scarborough, Inc.2016-08-18OCC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811877010538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081187701053810811877010538

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154148498
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
00811877012566BinaxNOW COVID-19/Flu A&B Combo Self Test200026032026-08-14
00811877012573BinaxNOW COVID-19/Flu A&B Combo Self Test200026062026-08-14
00811877012580BinaxNOW COVID-19/Flu A&B Combo Self Test200026042026-08-14
00811877012597BinaxNOW COVID-19/Flu A&B Combo Self Test200026072026-08-14
00811877012603BinaxNOW COVID-19/Flu A&B Combo Self Test200026052026-08-14
00811877012610BinaxNOW COVID-19/Flu A&B Combo Self Test200026082026-08-14
10811877010064ISOSTAT® Consumables50C92016-09-05
00811877012214BinaxNOW COVID-19/Flu A&B Combo Self Test200023502026-05-06
00811877012221BinaxNOW COVID-19/Flu A&B Combo Self Test200023512026-05-06
10811877011245WOUNDCHEK™ Bacterial Status360006US2020-05-26
00811877012153ID NOW InstrumentNAT-024R2025-08-01
00811877011477BinaxNOW COVID-19 Antigen Self Test195-1402023-09-05
00811877011118BinaxNOW COVID-19 Antigen Self Test195-1702023-08-11
00811877011729BinaxNOW COVID-19 Antigen Self Test195-1802022-10-03
00811877011408BinaxNOW COVID-19 Antigen Self Test195-1602021-04-21
10811877010934Osteomark NTx Urine90062020-09-16
10811877010941Osteomark NTx Serum90212020-09-16
00811877010050ISOSTAT® Press and Rack50C22016-09-05
00811877010098ISOSTAT® Containment Adapter50C12016-09-03
00811877012030BinaxNOW COVID-19/Flu A&B Combo Self Test20002050 2025-01-30

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Primary DI, Brand, Company table
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20816101029079LIAISON NES® Group A Strep Control Swab KitDIASORIN MOLECULAR LLCOOI2026-07-23
06954414749823GN 7120 Akso PCR SystemGetein Biotech,IncOOI2026-07-10
06954414795394GN 7000 Akso PCR SystemGetein Biotech,IncOOI2026-07-10
00850028489017MyrnaInflammatix, Inc.OOI2026-04-30
00850028489024TriVerityInflammatix, Inc.OOI2026-04-30
00875197005240cobas® Cdiff TestRoche Molecular Systems, Inc.OOI2026-02-24
00875197005288cobas® 4800 Cdiff Controls and Cofactor KitRoche Molecular Systems, Inc.OOI2026-02-24
00875197005677cobas® CdiffRoche Molecular Systems, Inc.OOI2026-02-23
00875197005684cobas® Cdiff Control KitRoche Molecular Systems, Inc.OOI2026-02-23
10816101025142LIAISON NES® InstrumentDIASORIN MOLECULAR LLCOOI2026-01-22
10816101025159LIAISON NES® Instrument (Refurbished)DIASORIN MOLECULAR LLCOOI2026-01-22
20816101029031LIAISON NES® FLU A/B, RSV & COVID-19DIASORIN MOLECULAR LLCOOI2026-01-22
20816101029048LIAISON NES® FLU A/B, RSV & COVID-19 Control Swab KitDIASORIN MOLECULAR LLCOOI2026-01-22
07332940009694GeneXpert®CEPHEIDOOI2026-01-19
20816101027358Simplexa COVID-19 / Flu A/B & RSV DirectDIASORIN MOLECULAR LLCOOI2026-01-14
20816101027365Simplexa COVID-19 / Flu A/B & RSV Positive Control PackDIASORIN MOLECULAR LLCOOI2026-01-14
30382904452798Enteric Bacterial Panel Diluent for BD COR™ SystemBECTON, DICKINSON AND COMPANYOOI2025-12-09
06955792701717Q-Vera Prima 96 qPCR InstrumentSansure Biotech Inc.OOI2025-11-19
06955792701670Q-Vera Prima 96 qPCR InstrumentSansure Biotech Inc.OOI2025-10-16
15420045517486Panther Fusion®Hologic, Inc.OOI2025-10-07
15420045517493Panther Fusion®Hologic, Inc.OOI2025-10-07
15420045517509Panther Fusion®Hologic, Inc.OOI2025-10-07
15420045517516Panther Fusion®Hologic, Inc.OOI2025-10-07
00850063063012DASH® Negative Control Swabs KitNuclein, LLCOCC2025-01-06
00850063063029DASH® SARS-CoV-2 & Flu A/B Positive Control Swabs KitNuclein, LLCOCC2025-01-06
00815381020727BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel MiniBIOFIRE DIAGNOSTICS, LLCOCC2024-07-26