Auto-antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/prothrombin Complex
Device Code: 3086
Product Code(s):
OPN Definition: For The Detection Of Autoantibodies To Phosphatidylserine (PS), Prothrombin (PT), Or Phosphatidylserine/prothrombin (PS/PT) Complex In Human Serum Or Plasma. To Aid In The Diagnosis Of Certain Autoimmune Thrombotic Disorders Such As Anti-phospholipid
Device Classification Information
| Device Type ID | 3086 |
| Device Name | Auto-antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/prothrombin Complex |
| Physical State | Microtiter Plate Coated With Purified Antigen, Enzyme Labelled Anti-human Antibody Substrate |
| Technical Method | ELISA |
| Target Area | Peripheral Blood Samples |
| Regulation Description | Multiple Autoantibodies Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5660 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OPN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3086 |
| Device | Auto-antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/prothrombin Complex |
| Product Code | OPN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Multiple Autoantibodies Immunological Test System. |
| CFR Regulation Number | 866.5660 [🔎] |
TPLC Last Update: 2019-04-02 20:23:37