Identity
- Trade Name
- QUANTA Lite® Phosphatidylserine IgA ELISA FDA UDI
- Generic Name
- Phosphatidylserine antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 1. Instruction leaflet: Giving full assay details. 2. QC Certificate: Indicating the expected performance of the batch. 3. Phosphatidylserine Coated Wells: 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: 2 bottles containing 50mL of buffer for sample dilution. Coloured straw, ready to use. 5. PBS Wash Concentrate (20x): 1 bottle containing 50mL of a 20-fold concentrated buffer for washing the wells. 6. Phosphatidylserine IgA ELISA Calibrators: 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 APS U/mL. Ready to use. 7. Phosphatidylserine IgA Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate.Ready to use. 8. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use. 9. HRP Phosphatidylserine IgA Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgA. Coloured green, ready to use. 10. TMB Chromogen: 1 bottle containing 10mL TMB substrate. Ready to use. 11. HRP Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric acid. Ready to use. FDA UDI
- Model / Reference
- 704635 FDA UDI
- Description
- 1. Instruction leaflet: Giving full assay details. 2. QC Certificate: Indicating the expected performance of the batch. 3. Phosphatidylserine Coated Wells: 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: 2 bottles containing 50mL of buffer for sample dilution. Coloured straw, ready to use. 5. PBS Wash Concentrate (20x): 1 bottle containing 50mL of a 20-fold concentrated buffer for washing the wells. 6. Phosphatidylserine IgA ELISA Calibrators: 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 APS U/mL. Ready to use. 7. Phosphatidylserine IgA Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate.Ready to use. 8. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use. 9. HRP Phosphatidylserine IgA Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgA. Coloured green, ready to use. 10. TMB Chromogen: 1 bottle containing 10mL TMB substrate. Ready to use. 11. HRP Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric acid. Ready to use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950593294 FDA UDI
- 510(k) Number
- K032240 FDA UDI
- FDA Product Code
- MID FDA UDI
- GMDN Term
- Phosphatidylserine antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Phosphatidylserine antibody IVD, kit, enzyme immunoassay (EIA)
QUANTA Lite® Phosphatidylserine IgA ELISA by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Phosphatidylserine antibody IVD, kit, enzyme immunoassay (EIA).
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- Corgenix Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit (192 Well) — CORGENIX MEDICAL CORPORATION · Class II
- REAADS Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit (96 Well) — CORGENIX MEDICAL CORPORATION · Class II
- REAADS Anti-Phosphatidylserine IgG/IgM Semi-Quantitative Test Kit (96 Well) — CORGENIX MEDICAL CORPORATION · Class II
- Autoimmune EIA — Bio-Rad Laboratories · Class II
- Autoimmune EIA — Bio-Rad Laboratories · Class II
Cleared under the same submission
K032240 also covers:
- QUANTA Lite® Phosphatidylserine IgA ELISA Bulk Pack — INOVA DIAGNOSTICS, INC.
- QUANTA Lite® Phosphatidylserine IgG ELISA — INOVA DIAGNOSTICS, INC.
- QUANTA Lite® Phosphatidylserine IgG ELISA Bulk Pack — INOVA DIAGNOSTICS, INC.
- QUANTA Lite® Phosphatidylserine IgM ELISA — INOVA DIAGNOSTICS, INC.
- QUANTA Lite® Phosphatidylserine IgM ELISA Bulk Pack — INOVA DIAGNOSTICS, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (1)
- FDA UDI aa25044d-77a4-493d-93bf-865da95abf9a 36 fields · synced May 30, 2026