FDA.reportPublic FDA data

AmpliVue

Primary DI
30014613312116
Brand
AmpliVue
Company
QUIDEL CORPORATION
Model
Trichomonas Assay
Catalog number
M211
Device description
AmpliVue Trichomonas Assay
Published
2016-09-15
Public version status
Update
Distribution status
Not 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
OUYTrichomonas vaginalis nucleic acid amplification test system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUYTrichomonas Vaginalis Nucleic Acid Amplification Test SystemImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143329000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143329000AmpliVue Trichomonas AssayQuidel Corporation2015-03-17OUY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613312116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461331211630014613312116

GMDN Terms#

Term, Definition table
TermDefinition
Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from the parasitic protozoan Trichomonas vaginalis in a clinical specimen, using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

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
00382904439248BD Molecular Urine Transport KitBECTON, DICKINSON AND COMPANYOUY2024-05-16
00382904439767BD Vaginal Panel on BD COR SystemBECTON, DICKINSON AND COMPANYOUY2024-04-02
30382904402960BD Molecular Swab Sample Buffer TubesBECTON, DICKINSON AND COMPANYOUY2024-02-26
30382904439232BD Molecular LBC Sample Buffer TubesBECTON, DICKINSON AND COMPANYOUY2024-02-23
00884999051096Alinity mABBOTT MOLECULAR INC.OUY2023-09-14
00810031720064Visby Medical Sexual Health TestVisby Medical, Inc.OUY2023-04-19
00810031720071Visby Medical Power Adapter, Right AngleVisby Medical, Inc.OUY2023-04-19
15420045514980APTIMAHologic, Inc.OUY2022-07-28
15420045514997APTIMAHologic, Inc.OUY2022-07-28
15420045515000APTIMAHologic, Inc.OUY2022-07-28
15420045515017APTIMAHologic, Inc.OUY2022-07-28
00382904439040BD CTGCTV2 for BD MAX™ SystemBECTON, DICKINSON AND COMPANYOUY2022-07-14
00382904439897BD COR™ MXBECTON, DICKINSON AND COMPANYOUY2022-06-16
00382904439798BD CTGCTV2BECTON, DICKINSON AND COMPANYOUY2022-06-08
00884999048898Alinity mABBOTT MOLECULAR INC.OUY2022-05-18
00884999047686Alinity mABBOTT MOLECULAR INC.OUY2022-05-18
00884999047693Alinity mABBOTT MOLECULAR INC.OUY2022-05-18
00884999049314Alinity mABBOTT MOLECULAR INC.OUY2022-05-18
00810031720002Visby Medical Sexual Health Click TestVisby Medical, Inc.OUY2021-09-15
00810031720033Visby Medical Power AdapterVisby Medical, Inc.OUY2021-09-15
00810031720057Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 PackVisby Medical, Inc.OUY2021-09-15
07332940002954Xpert Urine Specimen Collection KitCEPHEIDOUY2018-07-02
00382904429706BD MAX™ CT/GC/TVBECTON, DICKINSON AND COMPANYOUY2018-05-25
07332940001001Xpert TVCEPHEIDOUY2018-01-29
00382904437121BD MAX™ Vaginal PanelBECTON, DICKINSON AND COMPANYOUY2017-03-23
30382904433766BD MAX™ UVE Specimen Collection KitBECTON, DICKINSON AND COMPANYOUY2016-10-17
30382904434206BD MAX™ UVE Sample Buffer TubesBECTON, DICKINSON AND COMPANYOUY2016-10-17
00382904438241BD MAX™ CT/GC/TVGeneohm Sciences Canada IncOUY2016-10-17
30014613336396SolanaQUIDEL CORPORATIONOUY2016-09-16
30014613336402SolanaQUIDEL CORPORATIONOUY2016-09-16