Product Code: HZR FDA class 1 21 CFR 864.1850

Resorcin Fuchsin

Hematology

Resorcin Fuchsin is a histological stain used primarily to demonstrate elastic fibers in tissue sections, producing a dark purple-blue coloration on elastic tissue elements such as those found in blood vessel walls and skin. It is regulated as an FDA Class 1 device, the lowest risk level, subject to general controls only with no premarket notification required. The product code is HZR, regulated under 21 CFR 864.1850, in the Hematology medical specialty. This device is exempt from GMP requirements.

510(k)s
0
FEI Numbers
2
Registration Numbers
2
Unique Applicants
0
Years Active

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Basic Information

Product Code
HZR
Device Class
FDA class 1
Regulation Number
864.1850
Medical Specialty
Hematology
Review Panel
PA
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

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.