FDA.reportPublic FDA data

ELVIS

Primary DI
30014613333074
Brand
ELVIS
Company
DIAGNOSTIC HYBRIDS, INC.
Model
55-2418S
Catalog number
55-2418S
Device description
ELVIS MWP W24/18F WITH CS
Published
2018-08-07
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
GQLAntisera, fluorescent, herpesvirus hominis 1,2
GQNAntigen, cf (including cf control), herpesvirus hominis 1,2

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GQLAntisera, Fluorescent, Herpesvirus Hominis 1,2Microbiology2
GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2Microbiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091753000
K941924000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091753000ELVIS HSV ID AND D3 TYPING TEST SYSTEMDiagnostic Hybrids, Inc.2009-08-28GQL
K941924000ELVIS HSVDiagnostic Hybrids, Inc.1995-05-01GQN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613333074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333307430014613333074

GMDN Terms#

Term, Definition table
TermDefinition
Cell culture line IVDA cell line of known origin intended to be used alone or in combination with other IVDs, for cytogenetic analyses and/or for the detection/cultivation of viruses present in clinical laboratory specimens.

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
G5229025001Herpes Simplex Virus Type 1 / HSV-1 IgG IFA 96 TestHemagen Diagnostics, Inc.GQL2023-10-05
G5229025011Herpes Simplex Virus Type 1 / HSV-1 IgG IFA Slide Only KitHemagen Diagnostics, Inc.GQL2023-10-05
G522902600Herpes Simplex Virus Type 2 / HSV-2 IgG IFA 96 TestHemagen Diagnostics, Inc.GQL2023-10-05
G5229026011Herpes Simplex Virus Type 2 / HSV-2 IgG IFA Slides Only KitHemagen Diagnostics, Inc.GQL2023-10-05
04053252278679Light Diagnostics HSV 1 & 2 Control Slides (5 Pack)EMD Millipore CorporationGQL2020-04-16
04053252515101Light Diagnostics SimulFluor HSV 1/2 EMD Millipore CorporationGQN2020-04-16
04053252625213Light Diagnostics SimulFluor HSV 1/HSV 2 ReagentEMD Millipore CorporationGQN2020-04-16
04053252670930Light Diagnostics HSV 2 Typing ReagentEMD Millipore CorporationGQL2020-04-16
04053252678257Light Diagnostics HSV 1 Typing ReagentEMD Millipore CorporationGQL2020-04-16
04061841047469Light Diagnostics HSV 1 & 2 Control SlideEMD Millipore CorporationGQL2020-04-16
30014613336013ELVISDIAGNOSTIC HYBRIDS, INC.GQL2019-04-02
30014613336013ELVISDIAGNOSTIC HYBRIDS, INC.GQN2019-04-02
30014613336020ELVISDIAGNOSTIC HYBRIDS, INC.GQL2019-04-02
30014613336020ELVISDIAGNOSTIC HYBRIDS, INC.GQN2019-04-02
30014613330110ELVISDIAGNOSTIC HYBRIDS, INC.GQN2019-03-07
30014613330110ELVISDIAGNOSTIC HYBRIDS, INC.GQL2019-03-07
30014613330127ELVISDIAGNOSTIC HYBRIDS, INC.GQL2019-03-07
30014613330127ELVISDIAGNOSTIC HYBRIDS, INC.GQN2019-03-07
30014613330158ELVISDIAGNOSTIC HYBRIDS, INC.GQL2019-03-07
30014613330158ELVISDIAGNOSTIC HYBRIDS, INC.GQN2019-03-07
30014613330165ELVISDIAGNOSTIC HYBRIDS, INC.GQN2019-03-07
30014613330165ELVISDIAGNOSTIC HYBRIDS, INC.GQL2019-03-07
30014613330196ELVISDIAGNOSTIC HYBRIDS, INC.GQL2019-03-07
30014613330196ELVISDIAGNOSTIC HYBRIDS, INC.GQN2019-03-07
30014613330202ELVISDIAGNOSTIC HYBRIDS, INC.GQL2019-03-07
30014613330202ELVISDIAGNOSTIC HYBRIDS, INC.GQN2019-03-07
30014613332954ELVISDIAGNOSTIC HYBRIDS, INC.GQN2018-08-07
30014613332954ELVISDIAGNOSTIC HYBRIDS, INC.GQL2018-08-07
30014613332961ELVISDIAGNOSTIC HYBRIDS, INC.GQN2018-08-07
30014613332961ELVISDIAGNOSTIC HYBRIDS, INC.GQL2018-08-07