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REAADS Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit (96 Well)

FDA UDI

Class II (US FDA UDI)

by Corgenix Medical Corporation

Identity

Trade Name
REAADS Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit (96 Well) FDA UDI
Generic Name
Phosphatidylserine antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
INTENDED USE Detection and semi-quantitation of IgA anti-phosphatidylserine (aPS) antibodies as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use. SUMMARY AND EXPLANATION OF THE TEST High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. These antibodies have been associated with an increased risk for recurrent arterial and venous thrombotic events, thrombocytopenia, and fetal loss. Phosphatidylserine is a more physiologically relevant phospholipid due to its presence in cell membranes of endothelial cells and platelets. PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum/citrated plasma samples, calibrator sera, and controls are incubated in phosphatidylserine coated microwells. β2-glycoprotein I is provided in the sample diluent. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgA, labeled with horseradish peroxidase (HRP), are added forming complexes with the phosphatidylserine bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of IgA Antiphosphatidylserine (aPS) antibodies. Results are obtained by reading the O.D. (optical density or absorbance) of each well in a spectrophotometer. IgA calibrator sera are provided, expressed as APS (IgA anti-phosphatidylserine) units. Control and patient results are determined from the calibration curve. Refer to Package Insert. FDA UDI
Model / Reference
10206 FDA UDI
Description
INTENDED USE Detection and semi-quantitation of IgA anti-phosphatidylserine (aPS) antibodies as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use. SUMMARY AND EXPLANATION OF THE TEST High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. These antibodies have been associated with an increased risk for recurrent arterial and venous thrombotic events, thrombocytopenia, and fetal loss. Phosphatidylserine is a more physiologically relevant phospholipid due to its presence in cell membranes of endothelial cells and platelets. PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum/citrated plasma samples, calibrator sera, and controls are incubated in phosphatidylserine coated microwells. β2-glycoprotein I is provided in the sample diluent. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgA, labeled with horseradish peroxidase (HRP), are added forming complexes with the phosphatidylserine bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of IgA Antiphosphatidylserine (aPS) antibodies. Results are obtained by reading the O.D. (optical density or absorbance) of each well in a spectrophotometer. IgA calibrator sera are provided, expressed as APS (IgA anti-phosphatidylserine) units. Control and patient results are determined from the calibration curve. Refer to Package Insert. FDA UDI

Identifiers

Catalog Number
10206 FDA UDI
Primary DI / UDI-DI
00855360006106 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)

REAADS Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit (96 Well) by Corgenix Medical Corporation — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Phosphatidylserine antibody IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Corgenix Medical Corporation

Sources (1)

  • FDA UDI 151fba17-509a-47e8-a46f-7e2f286ea508 36 fields · synced Jun 8, 2026