FDA.reportPublic FDA data

QUANTA Flash® LKM-1 Reagents

Primary DI
08426950767008
Brand
QUANTA Flash® LKM-1 Reagents
Company
INOVA DIAGNOSTICS, INC.
Model
701298
Device description
"1. QUANTA Flash LKM-1 reagent cartridge contains the following reagents for 50 determinations:a. LKM-1 coated paramagnetic beads, lyophilized.b. Assay buffer – colored pink, containing protein stabilizers and preservatives.c. Tracer IgG – Isoluminol labeled anti-human IgG antibody, containing buffer, protein stabilizers and preservative.2. Resuspension buffer - colored clear, containing buffer, protein stabilizers and preservatives."""
Published
2017-12-15
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
NBSAutoantibodies,Lkm-1(Liver/Kidney Microsome,Type 1)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBSAutoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163538000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163538000QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 ControlsInova Diagnostics, Inc.2017-09-06NBS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950767008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950767008084269507670088426950767008

GMDN Terms#

Term, Definition table
TermDefinition
Liver-kidney microsome 1 antibody (anti-LKM1) 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 liver-kidney microsome 1 protein (anti-LKM1) in a clinical specimen, using a chemiluminescent immunoassay method. It is typically used to aid in the diagnosis of autoimmune hepatitis type 2.

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
04049016026808Anti-LKM-1 ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGNBS2016-09-24
04049016124887EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)EUROIMMUN Medizinische Labordiagnostika AGNBS2016-09-24
04049016124894EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)EUROIMMUN Medizinische Labordiagnostika AGNBS2016-09-24
05391516748728Trinity BiotechMARDX DIAGNOSTICS, INC.NBS2016-09-19
08426950593201QUANTA Lite® LKM- 1 ELISAINOVA DIAGNOSTICS, INC.NBS2016-08-31