Anesthesiology
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- Subpart B—Biological StainsCFR Sub-Part
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- Subpart F—Immunological Test SystemsCFR Sub-Part
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Test, Vaginal, Bacterial Sialidase
- Page Type
- Product Code
- Regulation Medical Specialty
- Microbiology
- Review Panel
- Chemistry
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 866.2660
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
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CFR § 866.2660 Microorganism differentiation and identification device
§ 866.2660 Microorganism differentiation and identification device.
(a) Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]