Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- MiscellaneousMiscellaneous
- PQOAnti-Müllerian Hormone Test System2Product Code
- MVOKit, Test, Multiple, Drugs Of Abuse, Over The CounterUProduct Code
- NGMTest, Phencyclidine (Pcp), Over The CounterUProduct Code
- OTWResearch Use Only/Clinical ToxicologyNProduct Code
- PUJVoriconazole Test System2Product Code
- OXR5-Fluorouracil AssayNProduct Code
- PDBInvestigational Use Only - Clinical ToxicologyNProduct Code
- PGEGastric Emptying Breath Test3Product Code
- PKMChemiluminescent Immunoassay SystemNProduct Code
- PRFDocetaxel / Paclitaxel AssayNProduct Code
- PSSMinoxidil Sulfotransferase Or Isoenzymes Test SystemNProduct Code
- QDRPlazomicin Test System, Immunoassay2Product Code
- LAOEnzyme Immunoassay, MethotrexateUProduct Code
- LCLRadioimmunoassay, PhencyclidineUProduct Code
- LCMEnzyme Immunoassay, PhencyclidineUProduct Code
- LTDParaquat Assay3Product Code
- MGXTest System, For Drugs Of Abuse3Product Code
- MIGStrip, Test IsoniazidUProduct Code
- MSKImmunoassay For Blood TacrolimusNProduct Code
- PZNPlacental Growth Factor TestNProduct Code
- QBBPlacental Alpha Microglobulin-1 Immunoassay3Product Code
- QWHPrognostic Test For Development Or Progression Of Preeclampsia2Product Code
- QXTInfliximab Test System2Product Code
- QYDAdalimumab Assay2Product Code
- QZHOpioid Use Disorder Genetic Risk Variant Detection System And Collection Kit3Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- 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
Anti-Müllerian Hormone Test System
- Page Type
- Product Code
- Definition
- An Anti-Müllerian hormone test system is an in vitro diagnostic device intended to measure anti-Müllerian hormone in human serum and plasma. The test is intended to be used as an aid for assessing ovarian reserve in women.
- Physical State
- In vitro diagnostic device, reagent
- Technical Method
- mmunoassay, other
- Target Area
- Fertility, diagnosis
- Regulation Medical Specialty
- Chemistry
- Review Panel
- Toxicology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 862.1092
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
Product code PQO is linked to regulation 21CFR862.1092, which does not seem to exist yet. It may be pending at the moment.