Reagent, Schiff
Schiff Reagent is a colorimetric reagent used in histochemistry for the periodic acid-Schiff (PAS) reaction, detecting polysaccharides, glycoproteins, and glycolipids in tissue sections by producing a magenta color on aldehyde-bearing structures. 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 HZT, 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
- HZT
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K883217 | SCHIFF REAGENT | Aug 05, 1988 | Substantially Equivalent | Surgipath Medical Industries, Inc. |
| K843752 | SIGMA PERIODIC ACID-SCHIFF STAIN 395 | Oct 30, 1984 | Substantially Equivalent | Sigma Chemical Co. |
| K842919 | SCHIFF REAGENT FUCHSIN-SULFUROUS ACID | Sep 11, 1984 | Substantially Equivalent | E K Ind., Inc. |
| K842917 | SCHIFF REAGENT, PAS STAIN | Sep 07, 1984 | Substantially Equivalent | E K Ind., Inc. |
| K760031 | HISTOCHEMICAL PAS REACTION SET | Jul 20, 1976 | Substantially Equivalent | Harleco |
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.