21 CFR 864.7300 — Fibrin Monomer Paracoagulation

Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7300

Product Codes

Product CodeDevice NameClassDevicesAttributes
JBNFibrin Monomer Paracoagulation22

Special Controls

JBN — Fibrin Monomer Paracoagulation

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. The special control for this device is FDA's “In Vitro Diagnostic Fibrin Monomer Paracoagulation Test.” See § 864.1(d) for information on obtaining this document.

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