FDA.reportPublic FDA data

MEDLINE

Primary DI
10197344173587
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
MPH1825FLU
Catalog number
MPH1825FLU
Device description
TEST,FLU A,CASSETTE,25 TESTS/BX
Published
2026-01-23
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
SCAMulti-analyte respiratory virus antigen detection test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SCAMulti-Analyte Respiratory Virus Antigen Detection TestMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20197344173584PackageGS118In Commercial Distribution
10197344173587PrimaryGS10
80197344173586Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019734417358420197344173584
1019734417358710197344173587
8019734417358680197344173586

GMDN Terms#

Term, Definition table
TermDefinition
Influenza A/B virus immunoglobulin M (IgM) antibody 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 immunoglobulin M (IgM) antibodies to influenza A virus and/or influenza B virus in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry; Keep away from sunlight. Store sealed at 36-86°F (2-30°C).

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
25
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197344216123MEDLINESSBCS21GLSSBCS21GL2026-07-24
10197344219575MEDLINEMDS99905MDS999052026-07-24
10653160391326MEDLINEEBSI1865EBSI18652026-07-24
30193489017742MEDLINE6651CBL22X16651CBL22X12026-07-24
30193489017759MEDLINE6651CBL22X26651CBL22X22026-07-24
30193489017766MEDLINE6651CBL22X36651CBL22X32026-07-24
30193489017773MEDLINE6651CBL22X46651CBL22X42026-07-24
30193489017780MEDLINE6651CBL34X36651CBL34X32026-07-24
30193489017797MEDLINE6651CBL34X46651CBL34X42026-07-24
30193489104893MEDLINEMDT011201XLMDT011201XL2026-07-24
40193489107969MEDLINEMDTISO3AHCAR3MDTISO3AHCAR32026-07-24
40193489120241MEDLINEMDTISO3AHGMDTISO3AHG2026-07-24
40193489120258MEDLINEMDTISO3AHG3XLMDTISO3AHG3XL2026-07-24
50080196247576MEDLINEMDT011205MDT0112052026-07-24
50193489109885MEDLINEMDTISO3AHY3XLMDTISO3AHY3XL2026-07-24
50193489109892MEDLINEMDTISO3AHYCARMDTISO3AHYCAR2026-07-24
10193489987522MEDLINEURO175814TURO175814T2022-05-22
10193489987546MEDLINEURO175818TURO175818T2022-05-22
10193489988505MEDLINEURO175816TURO175816T2022-05-22
00080196311661MEDLINENON241278NON2412782026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00087701190810Good Neighbor PharmacyAmerisourcebergen Drug CorporationSCA2026-07-08
00850010224442CareSuperb COVID-19/FluA&B Antigen Combo TestAccess Bio Inc.SCA2026-06-08
10850078377187iHealthiHealth Labs Inc.SCA2026-05-15
00850078377180iHealthiHealth Labs Inc.SCA2026-05-15
00850078377272iHealthiHealth Labs Inc.SCA2026-05-15
00811877012214BinaxNOW COVID-19/Flu A&B Combo Self TestAlere Scarborough, Inc.SCA2026-05-06
00811877012221BinaxNOW COVID-19/Flu A&B Combo Self TestAlere Scarborough, Inc.SCA2026-05-06
00311917077598WalgreensWALGREEN CO.SCA2026-04-28
00050428373927CVS Health WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDSCA2026-04-27
00840733101557statID Pro COVID-19/Flu External ControlsMERIDIAN BIOSCIENCE, INC.SCA2026-04-10
00840733101564statID Pro COVID-19/Flu A&BMERIDIAN BIOSCIENCE, INC.SCA2026-04-10
00810107290002Flowflex Plus COVID-19 + Flu A/B Home TestAcon Laboratories, Inc.SCA2026-01-30
00850078377227iHealthiHealth Labs Inc.SCA2026-01-30
00810107290033Flowflex Plus COVID-19 + Flu A/B Home TestAcon Laboratories, Inc.SCA2026-01-30
10850078377224iHealthiHealth Labs Inc.SCA2026-01-30
20197344173584MEDLINEMEDLINE INDUSTRIES, INC.SCA2026-01-23
00895160002960Nano-Check Influenza+COVID-19 Dual TestNANO-DITECH CORPORATIONSCA2026-01-16
10895160002967Nano-Check Influenza+COVID-19 Dual TestNANO-DITECH CORPORATIONSCA2026-01-16
00850078377098iHealthiHealth Labs Inc.SCA2026-01-02
00850078377104iHealthiHealth Labs Inc.SCA2026-01-02
00850078377128iHealthiHealth Labs Inc.SCA2026-01-02
00850078377135iHealthiHealth Labs Inc.SCA2026-01-02
10850078377095iHealthiHealth Labs Inc.SCA2026-01-02
10850078377101iHealthiHealth Labs Inc.SCA2026-01-02
10850078377125iHealthiHealth Labs Inc.SCA2026-01-02
10850078377132iHealthiHealth Labs Inc.SCA2026-01-02
00850010224381CareSuperb COVID-19/FluA&B Antigen Combo Home TestAccess Bio Inc.SCA2025-12-24
10612479277936McKessonMCKESSON MEDICAL-SURGICAL INC.SCA2025-12-03
40612479277944McKessonMCKESSON MEDICAL-SURGICAL INC.SCA2025-12-03
00810107290224Flowflex Plus RSV + Flu A/B + COVID Home TestAcon Laboratories, Inc.SCA2025-11-06