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
- 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
Test, Nitrite, Urinary, Non-Quantitative, Over The Counter
- Page Type
- Product Code
- Regulation Medical Specialty
- Chemistry
- Review Panel
- Toxicology
- Submission Type
- 510(K)
- Device Classification
- Class 1
- Regulation Number
- 862.1510
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 862.1510 Nitrite (nonquantitative) test system
§ 862.1510 Nitrite (nonquantitative) test system.
(a) Identification. A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin.
(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 2307, Jan. 14, 2000]