FDA.reportPublic FDA data

NOVA Lite® DAPI ANA Kit

Primary DI
08426950621843
Brand
NOVA Lite® DAPI ANA Kit
Company
INOVA DIAGNOSTICS, INC.
Model
704320
Device description
1. 20x ANA Hep- 2 -QR Slide (12 well)2. 1x 0.5mL IFA System Negative Control3. 1x 15mL FITC IgG Conjugate with DAPI 4. 1x 7mL Mounting Medium5. 2x 25mL PBS II Concentrate (40x)6 .1x Coverlips, 20 each7. 1x 0.5mL ANA Titratable Pattern
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
DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
PIVAutomated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, ControlImmunology2
PIVAutomated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical UseImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150155000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150155000NOVA Lite DAPI ANA KitInova Diagnostics, Inc.2015-04-08DHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950621843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950621843084269506218438426950621843

GMDN Terms#

Term, Definition table
TermDefinition
Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) 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
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
08426950627692QUANTA Flash PR3 Reagents7011352024-12-13
08430793040716Aptiva® APS IgG Reagent7251002024-03-11
08430793040853Aptiva® APS IgM Reagent7251402024-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00845533001960Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)ZEUS SCIENTIFIC, INC.PIV2025-05-12
00845533001977Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed)ZEUS SCIENTIFIC, INC.PIV2025-05-12
04250289513487AESKUSLIDES® ANA-HEp-2 gamma Aesku.Diagnostics GmbH & Co. KGDHN2025-04-06
04250289513562AESKUSLIDES® ANA-HEp-2 gamma Aesku.Diagnostics GmbH & Co. KGDHN2025-04-06
04260186120008HELIOS® Automated IFA SystemAesku.Diagnostics GmbH & Co. KGPIV2025-01-03
08059304340215dIFine ANA HEp-2 ClassifierVISIA LAB SRLPIV2024-11-08
08059304340215dIFine ANA HEp-2 ClassifierVISIA LAB SRLDHN2024-11-08
08059304340222dIFine DNA ClassifierVISIA LAB SRLPIV2024-11-08
04049016137894IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2024-09-11
G5229023441ANA/HEp-2 IgG IFA 96 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229023451ANA/HEp-2 IgG IFA 180 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229023601ANA/HEp-2 IgG IFA 600 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229023701ANA/HEp-2 IgG IFA 1200 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229023901ANA/HEp-2 IgG IFA 120 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229024201Anti-nDNA IgG IFA 96 TestHemagen Diagnostics, Inc.DHN2023-10-05
04049016152989IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2023-07-05
04250289512541HELIOS® AUTOMATED IFA SYSTEMAesku.Diagnostics GmbH & Co. KGPIV2023-06-25
00845533001861ZEUS NTx SerumZEUS SCIENTIFIC, INC.PIV2023-04-18
04049016148708EUROPattern ClassifierEUROIMMUN Medizinische Labordiagnostika AGPIV2022-12-08
08059304340109dIFine Automated Microscope VISIA LAB SRLPIV2022-09-07
08059304340109dIFine Automated Microscope VISIA LAB SRLDHN2022-09-07
08426951056538NOVA Lite® DAPI dsDNA Crithidia Luciliae KitINOVA DIAGNOSTICS, INC.PIV2021-03-31
00813545026561MeDiCaSCIMEDX CORPORATIONDHN2020-12-01
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00813545026905MeDiCaSCIMEDX CORPORATIONDHN2020-11-04
00813545026912MeDiCaSCIMEDX CORPORATIONDHN2020-11-04
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04260186125096HELIOSAesku.Systems GmbH & Co. KGPIV2020-03-02