Definition: According To The Regs..."..used After The Primary Diagnosis Of Tumor (neoplasm) Has Been Made By Conventional Histopathology Using Nonimmunologic Histochemical Stains, Such As Hematoxylin And Eosin.
| Device Type ID | 4896 |
| Device Name | Immunohistochemistry Reagents And Kits |
| 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 | NJT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4896 |
| Device | Immunohistochemistry Reagents And Kits |
| Product Code | NJT |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Immunohistochemistry Reagents And Kits. |
| CFR Regulation Number | 864.1860 [🔎] |
| Device Problems | |
|---|---|
False Negative Result | 2 |
Incorrect Or Inadequate Test Results | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
False Positive Result | 1 |
Device Operates Differently Than Expected | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 9 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | AMS Diagnostics, LLC | II | Mar-21-2014 |
| 2 | Biocare Medical Llc | II | Jan-13-2015 |
| 3 | Biocare Medical, LLC | II | Sep-19-2018 |
| 4 | Biocare Medical, LLC | II | Jul-05-2018 |
| 5 | Biocare Medical, LLC | III | Apr-19-2016 |
| 6 | Biocare Medical, LLC | II | Nov-09-2015 |
| 7 | Biocare Medical, LLC | III | May-26-2015 |
| 8 | Biocare Medical, LLC | II | Apr-27-2015 |
| 9 | Cell Marque Corporation | II | Jun-17-2016 |
| 10 | Lab Vision Corporation | III | Feb-17-2016 |
| 11 | Leica Biosystems Newcastle Ltd. | II | Jan-10-2014 |
| 12 | Leica Biosystems Richmond Inc. | II | Sep-12-2017 |
| 13 | Leica Microsystems, Inc. | II | Jun-01-2016 |
| 14 | Leica Microsystems, Inc. | II | May-21-2016 |
| 15 | Leica Microsystems, Inc. | II | Feb-19-2016 |
| 16 | Leica Microsystems, Inc. | II | Feb-12-2016 |
| 17 | Leica Microsystems, Inc. | II | Nov-25-2015 |
| 18 | Leica Microsystems, Inc. | II | Mar-24-2015 |
| 19 | Leica Microsystems, Inc. | II | Nov-06-2014 |
| 20 | Leica Microsystems, Inc. | II | Jun-04-2014 |
| 21 | Leica Microsystems, Inc. | II | Jun-02-2014 |
| 22 | Ventana Medical Systems Inc | I | Sep-14-2018 |
| 23 | Ventana Medical Systems Inc | I | Feb-27-2018 |