FDA.reportPublic FDA data

QUANTA Lite® PBC Screen IgG/IgA ELISA

Primary DI
08426950594239
Brand
QUANTA Lite® PBC Screen IgG/IgA ELISA
Company
INOVA DIAGNOSTICS, INC.
Model
704560
Device description
1. 1x PBC Screen IgG/IgA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted PBC Screen IgG/IgA ELISA Low Positive4. 1x 1.2mL prediluted PBC Screen IgG/IgA ELISA High Positive5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP PBC Screen IgG/IgA Conjugate, (goat), anti-human IgG/IgA8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
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
DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
NRIAutoantibodies, Nuclear Pore Glycoprotein Gp210
NUMAutoantibodies, Nuclear Body Protein, Sp100

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, ControlImmunology2
NRIAutoantibodies, Nuclear Pore Glycoprotein Gp210Immunology2
NUMAutoantibodies, Nuclear Body Protein, Sp100Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061842000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061842000QUANTA LITE PBC SCREEN IGG/IGA ELISAInova Diagnostics, Inc.2006-10-18NRI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950594239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950594239084269505942398426950594239

GMDN Terms#

Term, Definition table
TermDefinition
Multiple liver disease-associated antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with liver disease in a clinical specimen, using an enzyme immunoassay (EIA) method. The assayed antibodies may include autoimmune antibodies directed at liver-kidney microsome 1 protein (anti-LKM1), smooth muscle (anti-SMA), F-Actin, soluble liver antigen (SLA), Sp-100 protein, glycoprotein-210 (gp210), lamin B receptor (LBR) and also liver cytosol specific antibody type 1 (anti-LC1) and/or antimitochondrial antibodies (AMA).

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

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08426950621843NOVA Lite® DAPI ANA Kit7043202016-08-31
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