FDA.reportPublic FDA data

AmpliVue

Primary DI
30014613312123
Brand
AmpliVue
Company
QUIDEL CORPORATION
Model
Group A Strep Assay
Catalog number
M212
Device description
AmpliVue GAS 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
PGXGroups A, C and G beta-hemolytic streptococcus nucleic acid amplification system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141173000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141173000AMPLIVUE GAS ASSAYQuidel Corporation2014-07-24PGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613312123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461331212330014613312123

GMDN Terms#

Term, Definition table
TermDefinition
Beta-haemolytic Group A Streptococcus 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 Group A beta-haemolytic Streptococcus bacteria 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
00815381020727BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel MiniBIOFIRE DIAGNOSTICS, LLCPGX2024-07-26
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCPGX2024-05-03
00840733102325Revogene Strep AMERIDIAN BIOSCIENCE, INC.PGX2020-07-15
00628055344179Revogene® Strep AMeridian Bioscience Canada IncPGX2019-10-21
00628055344087GenePOC™ Strep AGenePoc IncPGX2019-04-30
10811877010552ID NOW Strep A 2Alere Scarborough, Inc.PGX2018-10-29
10811877010583ID NOW Strep A 2 Control Swab KitAlere Scarborough, Inc.PGX2018-10-29
30014613336136SolanaDIAGNOSTIC HYBRIDS, INC.PGX2018-07-23
07332940002503Xpert Xpress Strep ACEPHEIDPGX2018-06-29
10811877010040Alere i Strep A 2Alere Scarborough, Inc.PGX2018-06-28
10811877010200Alere i Strep A 2 Control Swab KitAlere Scarborough, Inc.PGX2018-06-28
07332940006372Xpert Xpress Strep ACEPHEIDPGX2018-01-29
07613336156544cobas Liat Strep A Script Version 1.27Roche Molecular Systems, Inc.PGX2017-11-17
00840487101469ARIES® Group A Strep AssayLUMINEX CORPORATIONPGX2017-11-07
07613336129692cobas® Liat® Strep A ScriptRoche Molecular Systems, Inc.PGX2016-09-24
00875197005622cobas® Strep A Nucleic acid test for use on the cobas® Liat® SystemRoche Molecular Systems, Inc.PGX2016-09-24
00875197005646cobas® Strep A Quality Control Kit for use on the cobas® Liat® SystemRoche Molecular Systems, Inc.PGX2016-09-24
20816101025569Simplexa™ Group A Strep DirectDIASORIN MOLECULAR LLCPGX2016-09-22
20816101025576Simplexa™ Group A Strep Positive Control PackDIASORIN MOLECULAR LLCPGX2016-09-22
30014613311126LyraQUIDEL CORPORATIONPGX2016-09-15
30014613336082SolanaQUIDEL CORPORATIONPGX2016-09-15
10811877010859Alere™ i Strep AAlere Scarborough, Inc.PGX2016-09-03
10811877010866Alere™ i Strep A Control Swab KitAlere Scarborough, Inc.PGX2016-09-03