NTVClass II
Myeloperoxidase, Immunoassay, System, Test
21 CFR 866.5600 / Immunology
NTV is the FDA product code for Myeloperoxidase, Immunoassay, System, Test, a class II device type, regulated under 21 CFR 866.5600. FDA's definition for this code reads: "MYELOPEROXIDASE, IMMUNOASSAY, SYSTEM, TEST IS INTENDED TO MEASURE MYELOPEROXIDASE IN HUMAN PLASMA, TO BE USED IN CONJUNCTION WITH CLINICAL HISTORY, ECG AND CARDIAC BIOMARKERS TO EVALUATE PATIENTS PRESENTING WITH CHEST PAIN THAT ARE AT RISK FOR MAJOR ADVERSE CARDIAC EVENTS, INCLUDING MYOCARDIAL INFARCTION, NEED FOR...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- NTV
- Device name
- Myeloperoxidase, Immunoassay, System, Test
- FDA definition
- MYELOPEROXIDASE, IMMUNOASSAY, SYSTEM, TEST IS INTENDED TO MEASURE MYELOPEROXIDASE IN HUMAN PLASMA, TO BE USED IN CONJUNCTION WITH CLINICAL HISTORY, ECG AND CARDIAC BIOMARKERS TO EVALUATE PATIENTS PRESENTING WITH CHEST PAIN THAT ARE AT RISK FOR MAJOR ADVERSE CARDIAC EVENTS, INCLUDING MYOCARDIAL INFARCTION, NEED FOR REVASCULARIZATION, OR DEATH.
- Regulation
- 21 CFR 866.5600
- Device class
- Class II
- Review panel
- Immunology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 2
- Ingested recalls
- 1
Clearances, product code NTV
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2008 | 1 |
Applicants with the most clearances
Product code NTV| Applicant | Clearances |
|---|---|
| Prognostix, Inc. | 1 |
| Siemens Healthcare Diagnostics Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.