FDA.reportPublic FDA data

ID NOW Influenza A & B Control Swab Kit

Primary DI
10811877010439
Brand
ID NOW Influenza A & B Control Swab Kit
Company
Alere Scarborough, Inc.
Model
425-080
Device description
Control Swabs intended for use only with the ID NOW Influenza A & B product.
Published
2018-10-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OCCRespiratory Virus Panel Nucleic Acid Assay System
OZEInfluenza A And Influenza B Multiplex Nucleic Acid Assay
PSZDevices Detecting Influenza A, B, And C Virus Antigens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCCRespiratory Virus Panel Nucleic Acid Assay SystemMicrobiology2
OZEInfluenza A And Influenza B Multiplex Nucleic Acid AssayMicrobiology2
PSZDevices Detecting Influenza A, B, And C Virus AntigensMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171792000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171792000Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab KitAlere Scarborough, Inc.2017-09-29OCC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811877010439PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081187701043910811877010439

GMDN Terms#

Term, Definition table
TermDefinition
Influenza A/B virus nucleic acid IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from influenza A virus and/or influenza B virus in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154148498
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00811877011729BinaxNOW COVID-19 Antigen Self Test195-1802022-10-03
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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
00811877012047BinaxNOW COVID-19/Flu A&B Combo Self Test20002056 2025-01-30
00811877012054BinaxNOW COVID-19/Flu A&B Combo Self Test200020512025-01-30
00811877012061BinaxNOW COVID-19/Flu A&B Combo Self Test20002057 2025-01-30
00811877012078BinaxNOW COVID-19/Flu A&B Combo Self Test20002052 2025-01-30
00811877012085BinaxNOW COVID-19/Flu A&B Combo Self Test20002058 2025-01-30
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