FDA.reportPublic FDA data

QUANTA Flash® dsDNA Reagents

Primary DI
08426950627760
Brand
QUANTA Flash® dsDNA Reagents
Company
INOVA DIAGNOSTICS, INC.
Model
701175
Device description
1 QUANTA Flash dsDNA Reagent Cartridge
Published
2016-08-31
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
LSWAnti-Dna Antibody, Antigen And Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSWAnti-Dna Antibody, Antigen And ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152013000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152013000QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA ControlsInova Diagnostics, Inc.2016-04-11LSW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950627760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950627760084269506277608426950627760

GMDN Terms#

Term, Definition table
TermDefinition
Double stranded DNA antibody (anti-dsDNA) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to double stranded DNA (anti-dsDNA) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-800-545-9495support@inovadx.com

Regulatory Flags#

DUNS number
188354831
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
08426950514190QUANTA Lite® C1q CIC ELISA7046202026-04-20
08430793041140Aptiva® Optical Cleaning SolutionAC10032024-03-11
08426950454373QUANTA Lite® ANA ELISA7087502016-08-31
08426950456193NOVA Lite® HEp-2 ANA Kit7081002016-08-31
08426950593461NOVA Lite® HEp-2 ANA Kit7081012016-08-31
08426950593577NOVA Lite® ANA Kit with DAPI7081022016-08-31
08426950594208NOVA Lite® HEp-2 External EB Kits7042352016-08-31
08426950594857NOVA Lite® Auto AB Panel 7081802016-08-31
08426950595267NOVA Lite® HEp-2 External EB Kits7042302016-08-31
08430793040181Aptiva® CTD Essential Calibrators7231012023-12-14
08430793040198Aptiva® CTD Essential Controls7231022023-12-14
08426950506324NOVA Lite® ANA KSL Kit7083902016-08-31
08426950514008NOVA Lite® ANA KSL Kit7083802016-08-31
08426950514176NOVA Lite®Rat Liver , Kidney, Stomach Kit7041702016-08-31
08426950545798NOVA Lite®Rat Liver , Kidney, Stomach Kit7041802016-08-31
08426950593539NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach7081502016-08-31
08426950596387NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach7081552016-08-31
08426950621843NOVA Lite® DAPI ANA Kit7043202016-08-31
08426950627692QUANTA Flash PR3 Reagents7011352024-12-13
08430793040716Aptiva® APS IgG Reagent7251002024-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250289513401AESKUSLIDES® nDNA (Crithidia luciliae)Aesku.Diagnostics GmbH & Co. KGLSW2024-11-15
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.LSW2023-12-14
00894175000237AccuDiag ™Diagnostic Automation, Inc.LSW2021-08-06
07333066019406EliA dsDNA WellPhadia ABLSW2019-03-06
07333066010557EliA dsDNA WellPhadia ABLSW2019-03-06
04250289510394AESKUSLIDES nDNA (Crithidia luciliae)Aesku.Diagnostics GmbH & Co. KGLSW2018-05-14
04250289503037AESKULISA® dsDNA-GAesku.Diagnostics GmbH & Co. KGLSW2017-03-17
04250289503440AESKULISA® dsDNA GAesku.Diagnostics GmbH & Co. KGLSW2017-02-28
B24235DSGHUE010Anti-ds-DNA-G ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.LSW2017-01-18
04250289500647AESKULISA® dsDNA-GAesku.Diagnostics GmbH & Co. KGLSW2016-09-27
08426950624646QUANTA Flash® dsDNA Reagents INOVA DIAGNOSTICS, INC.LSW2016-08-31