FDA.reportPublic FDA data

D3 Ultra

Primary DI
30014613330363
Brand
D3 Ultra
Company
DIAGNOSTIC HYBRIDS, INC.
Model
01-013000.V2-BULK
Catalog number
01-013000.V2-BULK
Device description
DFA Respiratory Virus Screening Reagent - Bulk
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
GNWANTISERA, CF, INFLUENZA VIRUS A, B, C

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GNWAntisera, Cf, Influenza Virus A, B, CMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092300000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092300000MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KITDiagnostic Hybrids, Inc.2009-08-28GNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613330363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333036330014613330363

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
ENTIINFG02900NovaLisa Influenza Virus A IgGGold Standard Diagnostics Frankfurt GmbHGNW2024-08-26
ENTIINFG03000NovaLisa Influenza Virus B IgGGold Standard Diagnostics Frankfurt GmbHGNW2024-08-26
ENTIINFG0290NovaLisa Influenza Virus A IgGGold Standard Diagnostics Frankfurt GmbHGNW2024-08-26
ENTIINFG0300NovaLisa Influenza Virus B IgGGold Standard Diagnostics Frankfurt GmbHGNW2024-08-26
05032384503070IMAGEN RESPIRATORY SCREEN POS CON SLIDEOXOID LIMITEDGNW2024-07-03
05032384503841IMAGEN Respiratory Screen KitOXOID LIMITEDGNW2024-06-19
04048474037937Influenza Virus A IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungGNW2023-08-31
04048474037968Influenza Virus B IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGNW2023-08-31
00840239037930Influenza Virus A IgG ELISA DRG International IncGNW2023-08-25
00840239037961Influenza Virus B IgG ELISADRG International IncGNW2023-08-25
B350GSD0130090Influenza A IgG ELISA Test KitGold Standard Diagnostics CorporationGNW2022-12-07
04053252270239Light Diagnostics ™ SimulFluor® Flu A / Flu B ReagentEMD Millipore CorporationGNW2022-12-01
04053252373435Light Diagnostics ™ Influenza A & B Control SlidesEMD Millipore CorporationGNW2022-12-01
04053252320439Light Diagnostics ™ Influenza A FITC-Labeled Monoclonal AntibodyEMD Millipore CorporationGNW2022-11-30
04053252368165Light Diagnostics ™ SimulFluor® Flu A/Flu B ReagentEMD Millipore CorporationGNW2022-11-30
04053252473722Light Diagnostics ™ Influenza B Monoclonal AntibodyEMD Millipore CorporationGNW2022-11-30
04053252789229Light Diagnostics ™ Influenza A & B Control SlideEMD Millipore CorporationGNW2022-11-30
04053252330094Light Diagnostics ™ Influenza B Monoclonal AntibodyEMD Millipore CorporationGNW2022-11-29
04053252470226Light Diagnostics ™ Influenza A Monoclonal AntibodyEMD Millipore CorporationGNW2022-11-29
04053252367588Light Diagnostics™ SimulFluor® Flu A/Flu B Immunofluorescence AssayEMD Millipore CorporationGNW2022-11-28
08436037124594Light Diagnostics™ Influenza A and B DFA KitEMD Millipore CorporationGNW2022-11-28
B350GSD0130100Influenza B IgG ELISA Test KitGold Standard Diagnostics CorporationGNW2022-10-07
00404847437935Influenza Virus A IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGNW2021-06-07
00404847437966Influenza Virus B IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGNW2021-06-07
30014613330288D3 UltraDIAGNOSTIC HYBRIDS, INC.GNW2019-03-07
30014613330295D3 UltraDIAGNOSTIC HYBRIDS, INC.GNW2019-03-07
30014613330301D3 UltraDIAGNOSTIC HYBRIDS, INC.GNW2019-03-07
30014613330318D3 UltraDIAGNOSTIC HYBRIDS, INC.GNW2019-03-07
30014613330325D3 UltraDIAGNOSTIC HYBRIDS, INC.GNW2019-03-07
30014613330349D3 UltraDIAGNOSTIC HYBRIDS, INC.GNW2019-03-07