Immunohistochemical Reagent, Antibody (monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells
Device Code: 4904
Product Code(s):
NTR Definition: MONOCLONAL OR POLYCLONAL ANTIBODY THAT RECOGNIZES THE HUMAN P63 PROTEIN IN THE NUCLEUS OF PROSTATIC BASAL CELLS USING ROUTINE IMMUNOHISTOCHEMICAL TECHNIQUES, INCLUDING HEAT-INDUCED ANTIGEN EPITOPE RETRIEVAL. THIS TEST IS INTENDED FOR LABORATORY USE T
Device Classification Information
| Device Type ID | 4904 |
| Device Name | Immunohistochemical Reagent, Antibody (monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells |
| Regulation Description | Immunohistochemistry Reagents And Kits. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.1860 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NTR |
| 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 | 4904 |
| Device | Immunohistochemical Reagent, Antibody (monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells |
| Product Code | NTR |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Immunohistochemistry Reagents And Kits. |
| CFR Regulation Number | 864.1860 [🔎] |
| Recalls |
|---|
| Manufacturer | Recall Class | Date Posted |
| 1 | Lab Vision Corporation | III | Nov-20-2015 |
TPLC Last Update: 2019-04-02 20:57:17