QUANTA Lite® Phosphatidylserine IgG ELISA Bulk Pack - 1. Instruction leaflet: Giving full assay - INOVA DIAGNOSTICS, INC.

Duns Number:188354831

Device Description: 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expect 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. Phosphatidylserine Coated Wells: 10 plates containing 12 breakapart 8 well strips coated with Phosphatidylserine antigen. Each plate is packaged in a re-sealable foil bag containing 2 desiccant pouches.4. PS Sample Diluent: 19 bottles containing 50mL of buffer for sample dilution. Coloured straw, ready to use.5. PBS Wash Concentrate (20x): 10 bottles containing 50mL of a 20-fold concentrated buffer for washing the wells. 6. Phosphatidylserine IgG ELISA Calibrators: 25 bottles (5 bottles each) containing 1.2mL of diluted human serum, with the following concentrations of anti-Phosphatidylserine autoantibody: 100, 33.3, 11.1, 3.7, 1.23 GPS U/mL. Ready to use.7. Phosphatidylserine IgG Positive Control: 5 bottles containing 1.2mL of diluted human serum. The expected value is given on the QC certificate.Ready to use.8. ELISA Negative Control: 5 bottles containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.9.HRP Phosphatidylserine IgG Conjugate: 10 bottles containing 10mL of purified peroxidase labelled antibody to human IgG. Coloured red, ready to use.10. TMB Chromogen: 10 bottles containing 10mL TMB substrate. Ready to use.11. HRP Stop Solution: 10 bottles containing 10mL of 0.344M Sulfuric acid. Ready to use.

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More Product Details

Catalog Number

-

Brand Name

QUANTA Lite® Phosphatidylserine IgG ELISA Bulk Pack

Version/Model Number

704625.10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K032240

Product Code Details

Product Code

MID

Product Code Name

System, Test, Anticardiolipin Immunological

Device Record Status

Public Device Record Key

151bb2a7-6d94-4334-b25d-76abffa8e226

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 31, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INOVA DIAGNOSTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 215