FDA.reportPublic FDA data

D3

Primary DI
30014613330660
Brand
D3
Company
DIAGNOSTIC HYBRIDS, INC.
Model
DFA Cytomegalovirus ID Kit
Catalog number
01-070000
Device description
D3 DFA Cytomegalovirus ID Kit
Published
2016-09-15
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
LINANTISERA, CONJUGATED FLUORESCENT, CYTOMEGALOVIRUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LINAntisera, Conjugated Fluorescent, CytomegalovirusMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081164000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081164000D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KITDiagnostic Hybrids, Inc.2008-06-13LIN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613330660PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333066030014613330660

GMDN Terms#

Term, Definition table
TermDefinition
Cytomegalovirus (CMV) antigen IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from cytomegalovirus (CMV) in a clinical specimen.

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
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
04053252507397Light Diagnostics CMV DFA ReagentEMD Millipore CorporationLIN2020-04-17
04053252282089Light Diagnostics CMV DFA ReagentEMD Millipore CorporationLIN2020-04-16
30014613330677D3DIAGNOSTIC HYBRIDS, INC.LIN2018-07-20
04053252368745Light Diagnostics™ CMV DFA KitEMD Millipore CorporationLIN2016-09-23
05391516745161Bartels®TRINITY BIOTECH PUBLIC LIMITED COMPANYLIN2016-09-23
05391516745871Bartels®TRINITY BIOTECH PUBLIC LIMITED COMPANYLIN2016-09-23
05391516745888Bartels®TRINITY BIOTECH PUBLIC LIMITED COMPANYLIN2016-09-23
05391516745901Bartels®TRINITY BIOTECH PUBLIC LIMITED COMPANYLIN2016-09-23
08717953022301CMV Brite™ Turbo, CMV antigenemia detection kitIQ Products B.V.LIN2016-09-19
08717953022318CMV Brite™ Turbo Control SlidesIQ Products B.V.LIN2016-09-19
08717953022356Reagent A - CMV Brite™ Turbo kitIQ Products B.V.LIN2016-09-19
08717953022363Reagent B - CMV Brite™ Turbo kitIQ Products B.V.LIN2016-09-19
08717953022370Reagent C - CMV Brite™ Turbo kitIQ Products B.V.LIN2016-09-19
08717953022387Reagent D - CMV Brite™ Turbo kitIQ Products B.V.LIN2016-09-19
08717953022394Reagent E - CMV Brite™ Turbo kitIQ Products B.V.LIN2016-09-19
08717953022325CMV Brite™[Only 5 CMV control slides], CMV Antigenemia Test KitIQ Products B.V.LIN2016-09-19
08717953022349CMV Brite™, CMV antigenemia detection kitIQ Products B.V.LIN2016-09-19