21 CFR 864.5425 — Control, Plasma, Abnormal
Hematology (HE) · Part 864 Subpart F—Automated and Semi-Automated Hematology Devices · § 864.5425
Identification
A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
Classification Rationale
Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GGC | Control, Plasma, Abnormal | 2 | 40 | |
| GGN | Plasma, Coagulation Control | 2 | 99 | |
| GIZ | Plasma, Control, Normal | 2 | 20 | |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | 180 | 3rd Party |
| LGP | Assay, Alpha-2-Antiplasmin | 2 | 5 | 3rd Party |
| LLG | Kit, Igg, Platelet Associated | 2 | 2 | 3rd Party |
Special Controls
GGC — Control, Plasma, Abnormal
*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
GGN — Plasma, Coagulation Control
*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
GIZ — Plasma, Control, Normal
*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
JPA — System, Multipurpose For In Vitro Coagulation Studies
*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
LGP — Assay, Alpha-2-Antiplasmin
*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
LLG — Kit, Igg, Platelet Associated
*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
