21 CFR 864.7925 — Activated Partial Thromboplastin
Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7925
Identification
A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GFO | Activated Partial Thromboplastin | 2 | 52 | 3rd Party |
| GGO | Reagent, Thromboplastin And Control | 2 | 1 | 3rd Party |
| GGW | Test, Time, Partial Thromboplastin | 2 | 32 | 3rd Party |
| GIT | Reagent & Control, Partial Thromboplastin Time | 2 | 4 | 3rd Party |
