FDA.reportPublic FDA data

D3 Fastpoint

Primary DI
30014613330851
Brand
D3 Fastpoint
Company
DIAGNOSTIC HYBRIDS, INC.
Model
01-123104
Catalog number
01-123104
Device description
L-DFA Influenza A/Influenza B 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
30014613330851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333085130014613330851

GMDN Terms#

Term, Definition table
TermDefinition
Influenza A/B 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 antigens from influenza A virus and/or influenza B virus in a clinical specimen, using a fluorescent immunoassay method.

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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04053252373411Light Diagnostics ™ Adenovirus Monoclonal AntibodyEMD Millipore CorporationGNY2022-11-29
04053252589591Light Diagnostics ™ RSV Monoclonal Antibody EMD Millipore CorporationLKT2022-11-29
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