FDA.reportPublic FDA data

D3 Fastpoint

Primary DI
30014613330837
Brand
D3 Fastpoint
Company
DIAGNOSTIC HYBRIDS, INC.
Model
01-120002.B2
Catalog number
01-120002.B2
Device description
FASTPOINT RSV/MPV KIT BX 2
Published
2018-07-22
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
LKTRESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA
OMGAntisera, fluorescent, human metapneumovirus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKTRespiratory Syncytial Virus, Antigen, Antibody, IfaMicrobiology1
OMGAntisera, Fluorescent, Human MetapneumovirusMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093233000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093233000D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KITDiagnostic Hybrids, Inc.2009-12-04OMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613330837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333083730014613330837

GMDN Terms#

Term, Definition table
TermDefinition
Multiple respiratory virus antigen IVD, kit, multiplexA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antigens from viruses associated with respiratory diseases in a clinical specimen, using a multiplex method. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
117359612
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
30014613330288D3 Ultra01-010000.V201-010000.V22019-03-07
30014613330875D3 Fastpoint01-12350401-1235042019-03-07
00050428101735CVS Health At Home COVID-19 Test Kit204522895862025-08-08
30014613340089Savanna20382R20382R2024-07-19
30014613339304Savanna20382203822024-04-30
30014613340188CVS Health At Home COVID-19 Test Kit204522895862024-11-20
30014613330240D301-0005001-000502019-04-02
30014613311034LyraM103M1032016-09-15
30014613311157Quidel MolecularM115M1152018-11-16
30014613330752D3 FastpointRespiratory Virus ID Kit01-1200002016-09-15
30014613330769D3 Fastpoint01-120000.B101-120000.B12018-07-22
30014613330776D3 Fastpoint01-120000.B201-120000.B22018-07-22
30014613330813D3 FastpointRSV/MPV ID Kit01-1200022016-09-15
30014613330820D3 Fastpoint01-120002.B101-120002.B12018-07-22
30014613336143SolanaM306M3062018-08-07
30014613338659D301-002007b01-002007b2019-04-23
30014613340119Savanna20445204452024-04-30
30014613340485SavannaM409-1M409-12024-04-30
30014613340492SavannaM409-4M409-42024-04-30
30014613330486D301-01501001-0150102023-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04053252282393Light Diagnostics ™ Respiratory Syncytial Virus (RSV) Control SlidesEMD Millipore CorporationLKT2022-12-01
04053252332555Light Diagnostics ™ SimulFluor® RSV/Para 3 ReagentEMD Millipore CorporationLKT2022-11-30
04053252472978Light Diagnostics ™ RSV FITC-Labeled Monoclonal AntibodyEMD Millipore CorporationLKT2022-11-30
04053252783234Light Diagnostics ™ Respiratory syncytial Virus (RSV) Control SlideEMD Millipore CorporationLKT2022-11-30
04053252589591Light Diagnostics ™ RSV Monoclonal Antibody EMD Millipore CorporationLKT2022-11-29
04053252732294Light Diagnostics™ SimulFluor® RSV/Para 3 DFA KitEMD Millipore CorporationLKT2022-11-28
08436037124624Light Diagnostics™ Respiratory Syncytial Virus DFA KitEMD Millipore CorporationLKT2022-11-28
05056080501680PathoDX Respiratory Viral PanelREMEL EUROPE LIMITEDLKT2021-07-21
05056080501697PathoDX Influenza A ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501703PathoDX Influenza B ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501710PathoDX Adenovirus ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501727PathoDx Parainfluenza 1 ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501734PathoDx Parainfluenza 2 ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501741PathoDx Parainfluenza 3 ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501758PathoDX RSV ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501765PathoDX Respiratory Mounting FluidREMEL EUROPE LIMITEDLKT2021-07-21
05056080501772PathoDX RVP Control SlidesREMEL EUROPE LIMITEDLKT2021-07-21
05056080501789PathoDX RSV Direct SpecimenREMEL EUROPE LIMITEDLKT2021-07-21
05056080501796 PathoDX RSV Control SlidesREMEL EUROPE LIMITEDLKT2021-07-21
04053252279362Light Diagnostics hMPV DFA ReagentEMD Millipore CorporationOMG2020-04-17
04061841047452Light Diagnostics hMPV Control SlideEMD Millipore CorporationOMG2020-04-17
04053252518584Light Diagnostics Human Metapneumovirus (hMPV) Control Slides (5 pack)EMD Millipore CorporationOMG2020-04-16
30014613330950D3DIAGNOSTIC HYBRIDS, INC.LKT2019-04-19
30014613330844D3 FastpointDIAGNOSTIC HYBRIDS, INC.LKT2019-03-07
30014613330844D3 FastpointDIAGNOSTIC HYBRIDS, INC.OMG2019-03-07
30014613330851D3 FastpointDIAGNOSTIC HYBRIDS, INC.LKT2019-03-07
30014613330851D3 FastpointDIAGNOSTIC HYBRIDS, INC.OMG2019-03-07
30014613330868D3 FastpointDIAGNOSTIC HYBRIDS, INC.OMG2019-03-07
30014613330868D3 FastpointDIAGNOSTIC HYBRIDS, INC.LKT2019-03-07
30014613330875D3 FastpointDIAGNOSTIC HYBRIDS, INC.LKT2019-03-07