FDA.reportPublic FDA data

NOVA Lite® DAPI ANCA (Ethanol) Kit

Primary DI
08426950767053
Brand
NOVA Lite® DAPI ANCA (Ethanol) Kit
Company
INOVA DIAGNOSTICS, INC.
Model
704338
Device description
1. 1 x 7mL Mounting Medium2. 1 x 15mL FITC IgG Conjugate with DAPI3. 1 x Coverslips (20 ea)4. 1 x 0.5mL IFA System Negative Control5. 1 x 0.5mL cANCA Positive6. 1 x 0.5mL pANCA Positive7. 20 x ANCA (Ethanol Fixed Human Neutrophil) Slide (12 well)8. 2 x 25mL PBS II Concentrate (40x)
Published
2017-06-12
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
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161258000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161258000NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitInova Diagnostics, Inc.2017-02-03MOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950767053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950767053084269507670538426950767053

GMDN Terms#

Term, Definition table
TermDefinition
Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple anti-neutrophil cytoplasmic antibodies (ANCA) in a clinical specimen, using a fluorescent 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
08059304340239dIFine ANCA ClassifierVISIA LAB SRLMOB2025-06-27
00845533001984Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)ZEUS SCIENTIFIC, INC.MOB2025-06-11
00845533001991Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed) ZEUS SCIENTIFIC, INC.MOB2025-06-11
00845533001960Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)ZEUS SCIENTIFIC, INC.MOB2025-05-12
00845533001977Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed)ZEUS SCIENTIFIC, INC.MOB2025-05-12
08426950627692QUANTA Flash PR3 ReagentsINOVA DIAGNOSTICS, INC.MOB2024-12-13
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00840239035974pANCA (MPO) ELISADRG International IncMOB2023-08-25
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00840239027788Proteinase-3 IgG ELISADRG International IncMOB2023-08-23
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00894175000404AccuDiag ™ Diagnostic Automation, Inc.MOB2021-08-09
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