21 CFR 864.7340 — Fibrinogen And Split Products, Rhodamine, Antigen, Antiserum, Control
Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7340
Identification
A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).
Classification Rationale
Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system 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 |
|---|---|---|---|---|
| DAR | Fibrinogen And Split Products, Rhodamine, Antigen, Antiserum, Control | 2 | 0 | 3rd Party |
| DAT | Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control | 2 | 2 | 3rd Party |
| DAX | Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control | 2 | 0 | 3rd Party |
| DAZ | Fibrinogen And Split Products, Antigen, Antiserum, Control | 2 | 0 | 3rd Party |
| GFK | Fibrinogen Determination Standards And Controls | 2 | 1 | 3rd Party |
| GFX | Fibrinogen Standard | 2 | 3 | |
| GIL | Plasma, Fibrinogen Control | 2 | 8 | |
| GIS | Test, Fibrinogen | 2 | 13 | 3rd Party |
| KQJ | System, Fibrinogen Determination | 2 | 28 | 3rd Party |
Special Controls
DAR — Fibrinogen And Split Products, Rhodamine, Antigen, Antiserum, Control
*Classification.* Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
DAT — Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control
*Classification.* Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
DAX — Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control
*Classification.* Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
DAZ — Fibrinogen And Split Products, Antigen, Antiserum, Control
*Classification.* Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
GFK — Fibrinogen Determination Standards And Controls
*Classification.* Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
GFX — Fibrinogen Standard
*Classification.* Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
GIL — Plasma, Fibrinogen Control
*Classification.* Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
GIS — Test, Fibrinogen
*Classification.* Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
KQJ — System, Fibrinogen Determination
*Classification.* Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
