Fibrinogen Standard
The Fibrinogen Standard (product code GFX) is a reference material used to calibrate laboratory assays that quantify fibrinogen, a key coagulation protein, in plasma samples, supporting accurate diagnosis of fibrinogen deficiency and coagulation disorders. This device is classified as FDA Class 2, indicating moderate risk, and does not require premarket notification under the current classification. Regulated under 21 CFR 864.7340 in the Hematology specialty (HE), this device carries no flags for implantation, life support, GMP exemption, or third-party review.
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Basic Information
- Product Code
- GFX
- Device Class
- FDA class 2
- Regulation Number
- 864.7340
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K072304 | FIBRINOGEN CALIBRATOR KIT | Sep 19, 2007 | Substantially Equivalent | Dade Behring, Inc. |
| K994341 | FIBRINOGEN CALIBRATOR KIT | Mar 03, 2000 | Substantially Equivalent | Dade Behring, Inc. |
| K812628 | ACA FIBRINOGEN CALIBRATOR | Nov 24, 1981 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.