Protamine Sulphate
Protamine Sulphate (product code GFT) is a hematology reagent used in laboratory tests, including the protamine sulfate test for fibrin monomers, to aid in the detection of disseminated intravascular coagulation (DIC) and assess fibrinogen polymerization. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.7525 in the Hematology specialty (HE), it is eligible for third-party review.
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Basic Information
- Product Code
- GFT
- Device Class
- FDA class 2
- Regulation Number
- 864.7525
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.