FDA.reportPublic FDA data

D3 Fastpoint

Primary DI
30014613330868
Brand
D3 Fastpoint
Company
DIAGNOSTIC HYBRIDS, INC.
Model
01-123304
Catalog number
01-123304
Device description
L-DFA RSV/MPV Reagent
Published
2019-03-07
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
GNSANTISERA, HAI, INFLUENZA VIRUS A, B, C
GNYANTISERA, FLUORESCENT, ADENOVIRUS 1-33
GQSANTIGENS, CF (INCLUDING CF CONTROL), PARAINFLUENZA VIRUS 1-4
LKTRESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA
OMGAntisera, fluorescent, human metapneumovirus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GNSAntisera, Hai, Influenza Virus A, B, CMicrobiology1
GNYAntisera, Fluorescent, Adenovirus 1-33Microbiology1
GQSAntigens, Cf (Including Cf Control), Parainfluenza Virus 1-4Microbiology1
LKTRespiratory Syncytial Virus, Antigen, Antibody, IfaMicrobiology1
OMGAntisera, Fluorescent, Human MetapneumovirusMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091171000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091171000D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KITDiagnostic Hybrids, Inc.2009-09-11OMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613330868PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333086830014613330868

GMDN Terms#

Term, Definition table
TermDefinition
Multiple respiratory virus antigen IVD, kit, fluorescent immunoassayA 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 fluorescent immunoassay 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
30014613330837D3 Fastpoint01-120002.B201-120002.B22018-07-22
30014613336143SolanaM306M3062018-08-07
30014613338659D301-002007b01-002007b2019-04-23
30014613340119Savanna20445204452024-04-30
30014613340485SavannaM409-1M409-12024-04-30
30014613340492SavannaM409-4M409-42024-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05032384502974IMAGEN Parainfluenza Virus Types 1, 2 and 3OXOID LIMITEDGQS2024-12-30
ENTIADVG00100NovaLisa Adenovirus IgGGold Standard Diagnostics Frankfurt GmbHGNY2024-08-26
ENTIADVG0010NovaLisa Adenovirus IgGGold Standard Diagnostics Frankfurt GmbHGNY2024-08-26
05032384502967IMAGEN PARAINFLUENZA VIRUS TYPES 1, 2, 3OXOID LIMITEDGQS2024-06-19
04048474034448Adenovirus Antigen (stool) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungGNY2023-08-29
04053252282393Light Diagnostics ™ Respiratory Syncytial Virus (RSV) Control SlidesEMD Millipore CorporationLKT2022-12-01
04053252286575Light Diagnostics ™ Respiratory Viral Control Slides (8 Well)EMD Millipore CorporationGNY2022-12-01
04053252473166Light Diagnostics ™ SimulFluor® Respiratory Screen KitEMD Millipore CorporationGNY2022-12-01
04053252507007Light Diagnostics ™ Respiratory Screen DFA ReagentEMD Millipore CorporationGNY2022-12-01
04053252508295Light Diagnostics ™ Adenovirus Control SlidesEMD Millipore CorporationGNY2022-12-01
04061839705098Light Diagnostics ™ SimulFluor® Respiratory Screen ReagentEMD Millipore CorporationGNY2022-12-01
04053252284311Light Diagnostics ™ Normal Mouse AntibodyEMD Millipore CorporationGNY2022-11-30
04053252332555Light Diagnostics ™ SimulFluor® RSV/Para 3 ReagentEMD Millipore CorporationLKT2022-11-30
04053252407239Light Diagnostics ™ SimulFluor® Respiratory Screen ReagentEMD Millipore CorporationGNY2022-11-30
04053252472978Light Diagnostics ™ RSV FITC-Labeled Monoclonal AntibodyEMD Millipore CorporationLKT2022-11-30
04053252586392Light Diagnostics ™ Respiratory Screen DFA ReagentEMD Millipore CorporationGNY2022-11-30
04053252624834Light Diagnostics ™ Adenovirus Control SlideEMD Millipore CorporationGNY2022-11-30
04053252627668Light Diagnostics ™ Adenovirus FITC-Labeled Monoclonal AntibodyEMD Millipore CorporationGNY2022-11-30
04053252783234Light Diagnostics ™ Respiratory syncytial Virus (RSV) Control SlideEMD Millipore CorporationLKT2022-11-30
04053252789168Light Diagnostics ™ Respiratory Viral Control SlideEMD Millipore CorporationGNY2022-11-30
08436037123078Light Diagnostics ™ Goat Anti-Mouse IgG FITC-Labeled AntibodyEMD Millipore CorporationGNY2022-11-30
04053252322235Light Diagnostics™ SimulFluor® Respiratory Screen KitEMD Millipore CorporationGNY2022-11-29
04053252373411Light Diagnostics ™ Adenovirus Monoclonal AntibodyEMD Millipore CorporationGNY2022-11-29
04053252589591Light Diagnostics ™ RSV Monoclonal Antibody EMD Millipore CorporationLKT2022-11-29
04053252675546Light Diagnostics ™ Respiratory Viral ScreenEMD Millipore CorporationGNY2022-11-29
04053252362064Light Diagnostics™ Respiratory Panel DFA KitEMD Millipore CorporationGNY2022-11-28
04053252589676Light Diagnostics™ Respiratory Viral Screen IFA KitEMD Millipore CorporationGNY2022-11-28
04053252732294Light Diagnostics™ SimulFluor® RSV/Para 3 DFA KitEMD Millipore CorporationLKT2022-11-28
08436037122651Light Diagnostics™ Respiratory Panel Viral Screening and Identification IFA KitEMD Millipore CorporationGNY2022-11-28
08436037124617Light Diagnostics™ Adenovirus DFA KitEMD Millipore CorporationGNY2022-11-28