QUANTA Lite® C1q CIC ELISA

Primary DI
08426950514190
Brand
QUANTA Lite® C1q CIC ELISA
Company
INOVA DIAGNOSTICS, INC.
Model
704620
Device description
1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. C1q CIC ELISA Plate: 12 breakapart 8 well strips coated with human C1q. Each plate is packaged in a re-sealable foil bag containing two desiccant pouch. 4.ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use5.C1q CIC Calibrator A- E: 5 bottles, each containing 1.2mL of diluted aggregated human IgG, with the following concentrations of immune complex: 100, 33.3, 11.1, 3.7, 1.23 microgram Eq/mL. Ready to use.6. C1q CIC Positive Control: 1 bottle containing 1.2mL of diluted aggregated human IgG. 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: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells.9. HRP C1q CIC IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Colored blue. Ready to use.10. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. Ready to use.11. HRP Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric Acid. Ready to use.
Published
2026-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DAKComplement C1q, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DAKComplement C1q, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031563000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031563000BINDAZYME CLQ CIC EIA KITThe Binding Site, Ltd.2003-09-10DAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950514190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950514190084269505141908426950514190

GMDN Terms#

Term, Definition table
TermDefinition
Non-specific circulating immune complex (CIC) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative non-specific detection of circulating immune complexes (CIC) in a clinical specimen (i.e., no antibody variable region binding and no specific disease/infection identification), using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
188354831
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00813545023737Scanlisa C1q Elisa 96 Test SCIMEDX CORPORATIONDAK2016-09-20
00813545023744C1q Plates & Calibrator Sets SCIMEDX CORPORATIONDAK2016-09-20
30014613335535MicroVueQUIDEL CORPORATIONDAK2016-09-15
30014613335559MicroVueQUIDEL CORPORATIONDAK2016-09-15
EBUHEKCIC1CIC-C1q ELISA KitBühlmann Laboratories AGDAK2016-09-01