Product Code: IAD FDA class 1 21 CFR 864.1850

Van Gieson'S Picro-Fuchsin

Hematology

Van Gieson's Picro-Fuchsin is a combined staining solution consisting of saturated picric acid and acid fuchsin, used in histology to distinguish collagen fibers (stained red) from muscle and cytoplasm (stained yellow) in tissue sections. It is regulated as an FDA Class 1 device, the lowest risk category, subject only to general controls without requiring premarket notification. The product code is IAD, 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
IAD
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.