FDA.reportPublic FDA data

NOVA Lite® DAPI dsDNA Crithidia Luciliae Kit

Primary DI
08426951056538
Brand
NOVA Lite® DAPI dsDNA Crithidia Luciliae Kit
Company
INOVA DIAGNOSTICS, INC.
Model
708215
Device description
1. 20 x 12-well bar-coded dsDNA (Crithidia luciliae) Slide2. 1 x 15mL FITC Anti-Human IgG Conjugate with DAPI3. 1 x 0.5mL dsDNA Positive4. 1 x 0.5mL IFA System Negative Control5. 2 x 25mL PBS II Concentrate (40x)6. 1 x 7mL Mounting Medium7. 1 x 20 Coverslips
Published
2021-03-31
Public version status
New
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
KTLAnti-Dna Indirect Immunofluorescent Solid Phase
PIVAutomated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTLAnti-Dna Indirect Immunofluorescent Solid PhaseImmunology2
PIVAutomated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical UseImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192916000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192916000NOVA Lite DAPI dsDNA Crithidia luciliae KitInova Diagnostics, Inc.2020-12-11KTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426951056538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426951056538084269510565388426951056538

GMDN Terms#

Term, Definition table
TermDefinition
Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent 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 fluorescent immunoassay method.

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
1-800-545-9495support@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
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00195126001038NOVA Lite® IFA Pancreatic Islet Cell Positive Control7040052026-06-09
00195126001045NOVA Lite® IFA Yo (PCA-1) Positive Control7040092026-06-09
08430793040761Aptiva® APS IgG Calibrators7251012024-03-11
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

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