IBD · Hyaluronidase
Pathology · 21 CFR 864.4400 · Class 1
Overview
| Product Code | IBD |
|---|---|
| Device Name | Hyaluronidase |
| Regulation | 21 CFR 864.4400 |
| Device Class | Class 1 |
| Review Panel | Pathology |
Identification
Enzyme preparations are products that are used in the histopathology laboratory for the following purposes:(1) To disaggregate tissues and cells already in established cultures for preparation into subsequent cultures (e.g., trypsin); (2) To disaggregate fluid specimens for cytological examination (e.g., papain for gastric lavage or trypsin for sputum liquefaction); (3) To aid in the selective staining of tissue specimens (e.g., diastase for glycogen determination).
Classification Rationale
Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
