FDA.reportPublic FDA data

QUANTA Lite® dsDNA SC ELISA

Primary DI
08426950544111
Brand
QUANTA Lite® dsDNA SC ELISA
Company
INOVA DIAGNOSTICS, INC.
Model
704650
Device description
1.Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. dsDNA SC Coated Wells: 12 breakapart 8 well strips coated with calf thymus dsDNA antigen. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches.4. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.5. dsDNA SC Calibrators: 5 bottles, each containing 1.2mL of diluted human serum, with the following concentrations of anti-dsDNA autoantibody: 1000, 333, 111, 37, 12.3 IU/mL. Ready to use.6. dsDNA SC Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.7. Type III Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored yellow, ready to use.8. HRP Wash Concentrate (40X): 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells.9.dsDNA SC Single Stranded Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.10. HRP dsDNA SC IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Colored blue. Ready to use.11. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. Ready to use.12. HRP Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric Acid. Ready to use.
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
LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993727000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993727000BINDAZYME ANTI-DSDNA EIA KITThe Binding Site, Ltd.1999-12-21LRM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950544111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950544111084269505441118426950544111

GMDN Terms#

Term, Definition table
TermDefinition
Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)A 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 an enzyme immunoassay (EIA) 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

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