FDA.reportPublic FDA data

InflammaDry

Primary DI
30014613336754
Brand
InflammaDry
Company
QUIDEL CORPORATION
Model
RPS-ID-20-U
Catalog number
RPS-ID-20-U
Device description
InflammaDry
Published
2019-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GODANTIGENS, CF (INCLUDING CF CONTROL), ADENOVIRUS 1-33

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GODAntigens, Cf (Including Cf Control), Adenovirus 1-33Microbiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613336754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333675430014613336754

GMDN Terms#

Term, Definition table
TermDefinition
Matrix metalloproteinase-9 (MMP-9) IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of matrix metalloproteinase-9 (MMP-9) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to aid in the diagnosis of dry eye syndrome. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(858)552-1100technicalsupport@quidel.com

Regulatory Flags#

DUNS number
079509836
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
30014613339755Sofia 220405204052023-03-28
30014613201090QuickVueOne-Step hCG Urine Test201092016-09-15
30014613339083Sofia20374203742021-02-17
30014613339229Sofia20377203772021-02-17
30014613339373QuickVue20387203872021-02-17
30014613337799Sofia20319203192019-12-10
30014613001782QuickVue+hCG S/U Test001782016-09-14
30014613001799QuickVue+hCG S/U Test001792016-09-14
30014613003434QuickVue In-Line00343003432018-11-10
30014613201083QuickVue20108201082018-11-10
30014613201106QuickVueOne-Step hCG Combo Test201102016-09-15
30014613201229QuickVue+20122201222018-11-10
30014613201250QuickVue20125201252018-11-10
30014613201939QuickVue20193201932018-11-10
30014613202011QuickVueiFOB Test202012016-09-15
30014613202059QuickVueiFOB Test202052016-09-15
30014613202189Sofia20218202182018-11-10
30014613202424Sofia20242202422018-11-10
30014613202547Sofia20254202542018-11-10
30014613202745Sofia20274202742018-11-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033891327606CHORUS ADENOVIRUS IgGDIESSE DIAGNOSTICA SENESE SPAGOD2024-01-22
04048474034462Adenovirus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGOD2023-08-29
00840239034465Adenovirus IgG ELISADRG International IncGOD2023-08-24
00404847434460Adenovirus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGOD2021-06-07
00840733101755PREMIER AdenocloneMERIDIAN BIOSCIENCE, INC.GOD2020-10-06
00840733101748PREMIER Adenoclone Type 40/41MERIDIAN BIOSCIENCE, INC.GOD2020-09-21
30014613336686AdenoPlusQUIDEL CORPORATIONGOD2018-11-10
04058863017792Quadrox-iMaquet Cardiopulmonary AGGOD2017-03-13
00722066001905Rapid ResponseBTNX IncGOD2016-10-25