Carbol Fuchsin
Carbol Fuchsin is a staining solution containing basic fuchsin in a phenol-alcohol base, used in microbiology and histology for acid-fast staining (Ziehl-Neelsen method) to detect mycobacteria such as Mycobacterium tuberculosis in tissue sections and smears. It is regulated as an FDA Class 1 device, the lowest risk level, subject to general controls without requiring premarket notification. The product code is ICL, regulated under 21 CFR 864.1850, in the Hematology medical specialty. This device is exempt from GMP requirements.
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Basic Information
- Product Code
- ICL
- Device Class
- FDA class 1
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K890148 | ATS TB RAPID STAIN SET PRODUCT #034-45 | Jan 24, 1989 | Substantially Equivalent | Alpha-Tec Systems, Inc. |
| K842933 | CARBOL-FUCHSIN, ZIEHL-NEEDSEN | Sep 11, 1984 | Substantially Equivalent | E K Ind., Inc. |
| K792483 | STAINS, COUNTERSTAINS & GEN. PURPOSE | Dec 18, 1979 | Substantially Equivalent | Laboratory Products, Inc. |
| K771390 | HISTOCHEMICAL AFB DEMONSTRATION | Aug 22, 1977 | Substantially Equivalent | Harleco |
FEI Numbers
This FDA classification entry is associated with 28 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 28 registration numbers. Click on an entry to view related FDA registrations.