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- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- LTBCyclosporine Radioimmunoassay2Product Code
- MARCyclosporine And Metabolites Serum Assay2Product Code
- MGSHigh Performance Liquid Chromatography For Cyclosporine2Product Code
- MGUFluorescence Polarization Immunoassay For Cyclosporine2Product Code
- MGVRadioimmunoassay For Cyclosporine2Product Code
- MKWCyclosporine2Product Code
- MLMEnzyme Immunoassay, Tracrolimus2Product Code
- NFXTest, Cholesterol, Total, Over The Counter1Product Code
- NFZTest, Creatinine, Over The Counter2Product Code
- NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter1Product Code
- NGDTest, Lactic Acid, Over The Counter1Product Code
- NGETest, Luteinizing Hormone (Lh), Over The Counter1Product Code
- NGJTest, Nitrite, Urinary, Non-Quantitative, Over The Counter1Product Code
- NGOTest, Triglycerides, Over The Counter1Product Code
- PQOAnti-Müllerian Hormone Test System2Product Code
- QKEImmunoassay, Pregnanediol Glucuronide, Over The Counter1Product Code
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Medical GeneticsReview Panel
- UnknownReview Panel
Immunoassay, Pregnanediol Glucuronide, Over The Counter
- Page Type
- Product Code
- Definition
- Over-the-counter detection of pregnanediol glucuronide for the confirmation of ovulation
- Physical State
- Immunoassay.
- Technical Method
- Immunoassay.
- Target Area
- In vitro diagnostic device.
- Regulation Medical Specialty
- Chemistry
- Review Panel
- Toxicology
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 862.1620
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 862.1620 Progesterone test system
§ 862.1620 Progesterone test system.
(a) Identification. A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.
(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 § 862.9.
[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]