FDA.report

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

Related Records

Contact Domains

Product Codes

CodeName
SCAMulti-analyte respiratory virus antigen detection test

Product Code Classifications

CodeDeviceSpecialtyClass
SCAMulti-Analyte Respiratory Virus Antigen Detection TestMicrobiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20197344173584PackageGS118In Commercial Distribution
10197344173587PrimaryGS10
80197344173586Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019734417358420197344173584
1019734417358710197344173587
8019734417358680197344173586

GMDN Terms

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

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

Sterilization Methods

Method

Contacts

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

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10197344039746MEDLINEHNX19100HNX191002024-10-11
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10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
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10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

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