Device Type ID | 3485 |
Device Name | Cryptosporidium Spp. |
Regulation Description | Entamoeba Histolytica Serological Reagents. |
Regulation Medical Specialty | Microbiology |
Review Panel | Microbiology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 866.3220 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | MHJ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
|
Device Type ID | 3485 |
Device | Cryptosporidium Spp. |
Product Code | MHJ |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Entamoeba Histolytica Serological Reagents. |
CFR Regulation Number | 866.3220 [🔎] |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
TECHLAB, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 |