FDA.reportPublic FDA data

MEDLINE

Primary DI
20197344173584
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
Rx
false
OTC
false
Sterile
false
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).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197344129099CURADCURCHSIL0753CURCHSIL07532026-06-09
00197344133812MEDLINEFRES2500FRES25002026-06-09
00197344133836MEDLINEFRES2501FRES25012026-06-09
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10197344142460MEDLINERTACHACMBRTACHACMB2026-06-09
10197344142477MEDLINERTACHACMGRTACHACMG2026-06-09
10197344142484MEDLINERTACHACMNRTACHACMN2026-06-09
10197344142491MEDLINERTACHACMPRTACHACMP2026-06-09
10197344142507MEDLINERTACHACMRRTACHACMR2026-06-09
10197344142514MEDLINERTACHACMYRTACHACMY2026-06-09
10197344142521MEDLINERTACHACMZRTACHACMZ2026-06-09
10197344143306MEDLINERTACHDAABRTACHDAAB2026-06-09
10197344143313MEDLINERTACHDAAGRTACHDAAG2026-06-09
10197344143320MEDLINERTACHDAANRTACHDAAN2026-06-09
10197344143337MEDLINERTACHDAAPRTACHDAAP2026-06-09
10197344143344MEDLINERTACHDAARRTACHDAAR2026-06-09
10197344143351MEDLINERTACHDAAYRTACHDAAY2026-06-09
10197344143368MEDLINERTACHDAAZRTACHDAAZ2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850010224442CareSuperb COVID-19/FluA&B Antigen Combo TestAccess Bio Inc.SCA2026-06-08
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 LAB INC.SCA2026-01-30
10197344173587MEDLINEMEDLINE 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 LAB INC.SCA2026-01-02
10850078377101iHealthIHEALTH LAB INC.SCA2026-01-02
10850078377125iHealthIHEALTH LAB INC.SCA2026-01-02
10850078377132iHealthIHEALTH LAB 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
30014613340751QuickVue™ WONDFO USA CO., LTD.SCA2025-10-31
B379RCFP251COVID/Flu A&B RespiraDXTM Rapid TestINBIOS INTERNATIONAL, INCSCA2025-10-06