11-dehydro Thromboxane B2 Kit, Urinary
Device Code: 2432
Product Code(s):
OBW Definition: The Test Kit Is An Enzyme-linked Immunoassay (elisa) To Determine Levels Of 11-dehydro Thromboxane B2 (11dhtxb2) In Human Urine, Which Aids In The Qualitative Detection Of Aspirin Effect In Apparently Healthy Individuals Post Ingestion. For Professio
Device Classification Information
| Device Type ID | 2432 |
| Device Name | 11-dehydro Thromboxane B2 Kit, Urinary |
| Physical State | N/a |
| Technical Method | An Enzyme Linked Immunosorbent Assay (ELISA) For The Detection Of 11dhTxB2. |
| Target Area | N/a |
| Regulation Description | Automated Platelet Aggregation System. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 864.5700 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OBW |
| 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 | 2432 |
| Device | 11-dehydro Thromboxane B2 Kit, Urinary |
| Product Code | OBW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Automated Platelet Aggregation System. |
| CFR Regulation Number | 864.5700 [🔎] |
| Device Problems |
|---|
Improper Or Incorrect Procedure Or Method | 1 |
| Total Device Problems | 1 |
TPLC Last Update: 2019-04-02 20:11:56