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- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
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- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- DJREnzyme Immunoassay, Methadone2Product Code
- PFTReagents For Molecular Diagnostic Test Systems1Product Code
- QKTClozapine Test System2Product Code
- DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method2Product Code
- DIDBacillus Subtilis Microbiology Assay, Tobramycin2Product Code
- DIEHeavy Metals Control Materials1Product Code
- DIFDrug Mixture Control Materials1Product Code
- DIGCholinesterase Test Paper1Product Code
- DIHColorimetry, Cholinesterase1Product Code
- DIJLead, Delta Amino Levulinic Acid2Product Code
- DIKThin Layer Chromatography, Quinine1Product Code
- DILRadioimmunoassay, Primidone2Product Code
- DIMGas Chromatography, Salicylate2Product Code
- DINGas Chromatography, Cocaine2Product Code
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites2Product Code
- DIPEnzyme Immunoassay, Diphenylhydantoin2Product Code
- DIQRadioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep.2Product Code
- DIRFree Radical Assay, Cocaine2Product Code
- DISEnzyme Immunoassay, Barbiturate2Product Code
- DITThin Layer Chromatography, Amphetamine2Product Code
- DIWHemagglutination Inhibition, Methadone2Product Code
- DIXThin Layer Chromatography, Phenobarbital2Product Code
- DIYGas Chromatography, Ethosuximide2Product Code
- DIZDelayed Analysis, Alcohol2Product Code
- DJBRadioimmunoassay, Gentamicin (125-I), Second Antibody Sep.2Product Code
- DJCThin Layer Chromatography, Methamphetamine2Product Code
- DJDEnzyme Immunoassay, Primidone2Product Code
- DJEThin Layer Chromatography, Salicylate2Product Code
- DJFGas Chromatography, Opiates2Product Code
- DJGEnzyme Immunoassay, Opiates2Product Code
- DJHGas Chromatography, Phenobarbital2Product Code
- DJIAntiserum, Gentamicin2Product Code
- DJJFluorometry, Morphine2Product Code
- DJKDigitoxin Control Serum, Ria1Product Code
- DJLFree Radical Assay, Amphetamine2Product Code
- DJNMercury Dithiazone, Colorimetry, Barbiturate2Product Code
- DJPRadioimmunoassay, Amphetamine2Product Code
- DJQTest Reagents For Phenothiazine2Product Code
- DJXRadioimmunoassay, Ethosuximide2Product Code
- DJZDevices, Breath Trapping, Alcohol1Product Code
- DKAAntiserum, Digoxin2Product Code
- DKBCalibrators, Drug Mixture2Product Code
- DKCAlcohol Control Materials1Product Code
- DKDBacillus Subtilis, Microbiological Assay, Gentamicin2Product Code
- DKEReagents, Test, Tetrahydrocannabinol2Product Code
- DKHGas Chromatography, Diphenylhydantoin2Product Code
- DKJColorimetry, Salicylate2Product Code
- DKNRadioimmunoassay, Barbiturate2Product Code
- DKPRadioimmunoassay, Phenobarbital2Product Code
- DKQAntiserum, Digitoxin2Product Code
- DKRThin Layer Chromatography, Methadone2Product Code
- DKTFree Radical Assay, Opiates2Product Code
- DKWTest Reagents For Sulphanimide Derivatives1Product Code
- DKXThin Layer Chromatography, Barbiturate2Product Code
- DKZEnzyme Immunoassay, Amphetamine2Product Code
- DLATest Reagents For Methyl Alcohol2Product Code
- DLBRadioimmunoassay, Lsd (125-I)2Product Code
- DLDThin Layer Chromatography, Codeine2Product Code
- DLEReagents, Test, Bromides2Product Code
- DLFEnzyme Immunoassay, Ethosuximide2Product Code
- DLHGas Chromatography, Alcohol2Product Code
- DLIAcetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase1Product Code
- DLJCalibrators, Drug Specific2Product Code
- DLNHemagglutination, Cocaine Metabolites (Benzoylecgnonine)2Product Code
- DLPRadioimmunoassay, Diphenylhydantoin2Product Code
- DLRHemagglutination Inhibition, Morphine2Product Code
- DLSGas Chromatograph, Alcohol (Dedicated Instruments)2Product Code
- DLTHemagglutination, Opiates2Product Code
- DLXHemagglutination Inhibition, Barbiturate2Product Code
- DLZEnzyme Immunoassay, Phenobarbital2Product Code
- DMBGas Chromatography, Methadone2Product Code
- DMFGas Liquid Chromatography, Barbiturate2Product Code
- DMIPotassium Dichromate Specific Reagent For Alcohol2Product Code
- DMJTest Reagents For Ethyl Alcohol2Product Code
- DMKLead, Protoporphyrin, Fluorometric2Product Code
- DMLNad-Nadh, Specific Reagent For Alcohol Enzyme Method2Product Code
- DMNThin Layer Chromatography, Cocaine2Product Code
- DMPDigoxin Control Serum, Ria1Product Code
- DMQGas Chromatography, Primidone2Product Code
- DMRSolution, M-Nitrophenol, Specific Reagent For Cholinesterase1Product Code
- DMTEnzymatic Method, Alcohol Dehydrogenase, Ultraviolet2Product Code
- DMXLiquid Chromatography, Salicylate2Product Code
- DMYGas Chromatography, Morphine2Product Code
- DNARadioimmunoassay, Morphine-Barbiturate (125-I), Goat Antibody2Product Code
- DNCStrip, Paper, Salicylate2Product Code
- DNDRadioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep.2Product Code
- DNEAtomic Absorption, Antimony1Product Code
- DNFLiquid Chromatography, Ethosuximide2Product Code
- DNGFree Radical, Benzoylecgnonine2Product Code
- DNILiquid Chromatography, Amphetamine2Product Code
- DNJRadioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.2Product Code
- DNKThin Layer Chromatography, Morphine2Product Code
- DNLRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.2Product Code
- DNNCalibrators, Ethyl Alcohol2Product Code
- DNOHemagglutination Inhibition, Gentamicin2Product Code
- DNPThin Layer Chromatography, Ethosuximide2Product Code
- DNQRadioimmunoassay, Digoxin (3-H), Rabbit Antibody, Coated Tubes Sep.2Product Code
- DNSRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Double Label Sep.2Product Code
- DNTLiquid Chromatography, Methadone2Product Code
- DNWRadioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Charcoal Sep.2Product Code
- DNXLead, Protoporphyrin Zinc Method, Fluorometric2Product Code
- DNZAtomic Absorption, Arsenic1Product Code
- DOARadioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.2Product Code
- DOBRadioimmunoassay, Digitoxin (3-H)2Product Code
- DODGas Chromatography, Amphetamine2Product Code
- DOERadioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.2Product Code
- DOFLead, Atomic Absorption2Product Code
- DOGRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol2Product Code
- DOHElectrometry, Cholinesterase1Product Code
- DOJPotassium Dichromate, Alcohol2Product Code
- DOKFree Radical Assay, Morphine2Product Code
- DOLFree Radical Assay, Lsd2Product Code
- DOMThin Layer Chromatography, Benzoylecgnonine2Product Code
- DONRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.2Product Code
- DOOLiquid Chromatography, Phenobarbital2Product Code
- DORRadioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep.2Product Code
- DOSThin Layer Chromatography, Primidone2Product Code
- DOWRadioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Coated Tube2Product Code
- DOXFluorometer, Lead (Dedicated Instruments)2Product Code
- DOYRadioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.2Product Code
- DOZLiquid Chromatography, Diphenylhydantoin2Product Code
- DPBRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.2Product Code
- DPDRadioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal Sep.2Product Code
- DPEThin Layer Chromatography, Diphenylhydantoin2Product Code
- DPGRadioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.2Product Code
- DPHMercury, Atomic Absorption1Product Code
- DPIRadioimmunoassay, Digoxin (125-I), Bovine Antibody, Charcoal Sep.2Product Code
- DPJRadioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep.2Product Code
- DPKLiquid Chromatography, Morphine2Product Code
- DPLRadioimmunoassay, Digitoxin (125-I), Bovine Antibody, Charcoal Sep.2Product Code
- DPNThin Layer Chromatography, Propoxyphene2Product Code
- DPORadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.2Product Code
- DPPFree Radical Assay, Methadone2Product Code
- DPQLiquid Chromatography, Primidone2Product Code
- JIHFlame Photometry, Lithium2Product Code
- JIIAtomic Absorption, Lithium2Product Code
- JKQGold Chloride (Colorimetric), Bromide2Product Code
- JKSSpectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide1Product Code
- JKTGas Chromatograph, Carbon-Monoxide1Product Code
- JXMEnzyme Immunoassay, Benzodiazepine2Product Code
- JXNEnzyme Immunoassay, Propoxyphene2Product Code
- JXOEnzyme Immunoassay, Cocaine2Product Code
- KJIRadioimmunoassay, Kanamycin2Product Code
- KLBRadioimmunoassay, Tobramycin2Product Code
- KLNRadioimmunoassay, Cocaine Metabolite2Product Code
- KLOEnzymatic Radiochemical Assay, Gentamicin2Product Code
- KLPAmikacin Serum Assay2Product Code
- KLQRadioimmunoassay, Amikacin2Product Code
- KLREnzyme Immunoassay, Lidocaine2Product Code
- KLSEnzyme Immunoassay, Theophylline2Product Code
- KLTEnzyme Immunoassay, Carbamazepine2Product Code
- KXSRadioimmunoassay, Methaqualone2Product Code
- KXTEnzyme Immunoassay, Digoxin2Product Code
- KZTKit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin2Product Code
- KZWKit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Kanamycin2Product Code
- KZXKit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin2Product Code
- KZYHigh Pressure Liquid Chromatography, Barbiturate2Product Code
- KZZGas Chromatography, Benzodiazepine2Product Code
- LAAHigh Pressure Liquid Chromatography, Benzodiazepine2Product Code
- LABThin Layer Chromatography, Benzodiazepine2Product Code
- LACHigh Pressure Liquid Chromatography, Cocaine And Cocaine Metabolites2Product Code
- LADGas Chromatography, Codeine2Product Code
- LAEHigh Pressure Liquid Chromatography, Codeine2Product Code
- LAFGas Chromatography, Methamphetamine2Product Code
- LAGHigh Pressure Liquid Chromatography, Methamphetamine2Product Code
- LAHHigh Pressure Liquid Chromatography, Opiates2Product Code
- LAIThin Layer Chromatography, Opiates2Product Code
- LAJGas Chromatography, Propoxyphene2Product Code
- LAKHigh Pressure Liquid Chromatography, Propoxyphene2Product Code
- LALEas Chromatography, Quinine1Product Code
- LAMHigh Pressure Liquid Chromatography, Quinine1Product Code
- LANEnzyme Immunoassay, N-Acetylprocainamide2Product Code
- LAREnzyme Immunoassay, Procainamide2Product Code
- LASDrug Specific Control Materials1Product Code
- LATRadioimmunoassay, Cannabinoid(S)2Product Code
- LAWTheophylline Control Materials1Product Code
- LAXLidocaine Control Materials1Product Code
- LAYMethotrexate Control Materials1Product Code
- LAZN-Acetylprocainamide Control Materials1Product Code
- LBAProcainamide Control Materials1Product Code
- LBZEnzyme Immunoassay, Quinidine2Product Code
- LCARadioimmunoassay, Theophylline2Product Code
- LCDEnzyme Immunoassay, Gentamicin2Product Code
- LCERadioimmunoassay, Netilmicin (I-125)2Product Code
- LCQFluorescent Immunoassay Gentamicin2Product Code
- LCRFluorescent Immunoassay, Tobramycin2Product Code
- LCSRadioimmunoassay, Digoxin (125-I)2Product Code
- LCTRadioimmunoassay, Digoxin (3-H)2Product Code
- LCWRadioimmunoassay, Digitoxin (125-I)2Product Code
- LCYU.V. Spectrometry, Theophylline2Product Code
- LCZU.V. Spectrometry, Primidone2Product Code
- LDAU.V. Spectrometry, Phenobarbital2Product Code
- LDBU.V. Spectrometry, Carbamazepine2Product Code
- LDCU.V. Spectrometry, Diphenylhydantoin2Product Code
- LDJEnzyme Immunoassay, Cannabinoids2Product Code
- LDNEnzymatic Radiochemical Assay, Amikacin2Product Code
- LDOEnzymatic Radiochemical Assay, Tobramycin2Product Code
- LDPColorimetry, Acetaminophen2Product Code
- LEGEnzyme Immunoassay, Valproic Acid2Product Code
- LEHRadioimmunoassay, Vancomycin2Product Code
- LERFluorescent Immunoassay, Theophylline2Product Code
- LESFluorescent Immunoassay, Diphenylhydantoin2Product Code
- LETFluorescent Immunoassay, Phenobarbital2Product Code
- LEWThin Layer Chromatography, Theophylline2Product Code
- LFGRadioimmunoassay, Tricyclic Antidepressant Drugs2Product Code
- LFHU.V. Spectrometry, Tricyclic Antidepressant Drugs2Product Code
- LFIHigh Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs2Product Code
- LFMEnzyme Immunoassay, Digitoxin2Product Code
- LFNNephelometric Inhibition Immunoassay, Phenobarbital2Product Code
- LFONephelometric Inhibition Immunoassay, Diphenylhydantoin2Product Code
- LFTFluorescent Immunoassay, Primidone2Product Code
- LFWFluorescence Polarization Immunoassay, Tobramycin2Product Code
- LGIFluorescence Polarization Immunoassay, Carbamazepine2Product Code
- LGJFluorescence Polarization Immunoassay, Amibacin2Product Code
- LGQFluorescence Polarization Immunoassay, Phenobarbital2Product Code
- LGRFluorescence Polarization Immunoassay, Diphenylhydantoin (Total)2Product Code
- LGSFluorescence Polarization Immunoassay, Theophylline2Product Code
- LPXRadioceptor Assay, Neuroleptic Drugs2Product Code
- MKUEnzyme Immunoassay, Nicotine And Nicotine Metabolites1Product Code
- MLKThin Layer Chromatography, Tricyclic Antidepressant Drugs2Product Code
- MOJFluorescence Polarization Immunoassay, Diphenylhydantoin (Free)2Product Code
- MRSTest System, Nicotine, Cotinine, Metabolites1Product Code
- MSLSystem, Test, Topiramatee2Product Code
- NDWAssay, Porphyrin, Spectrophotometry, Lithium2Product Code
- NFTTest, Amphetamine, Over The Counter2Product Code
- NFVTest, Benzodiazepine, Over The Counter2Product Code
- NFWTest, Cannabinoid, Over The Counter2Product Code
- NFYTest, Cocaine And Cocaine Metabolites, Over The Counter2Product Code
- NGGTest, Methamphetamine, Over The Counter2Product Code
- NGITest, Morphine, Over The Counter2Product Code
- NGLTest, Opiates, Over The Counter2Product Code
- NRPSirolimus Test System2Product Code
- NTIDrug Metabolizing Enzyme Genotyping Systems2Product Code
- NWMImmunoassay, Anti-Seizure Drug2Product Code
- OAVMycophenolic Acid Test System2Product Code
- ODWCytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System2Product Code
- OIWSoftware, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types2Product Code
- ORABreast Milk-Alcohol Test System2Product Code
- ORHLamotrigine Assay2Product Code
- ORILevetiracetam Assay2Product Code
- OTFGabapentin Assay2Product Code
- OUFEverolimus Immunoassay2Product Code
- PDYOrganophosphate Test System2Product Code
- POXEnzyme Immunoassay, Oxcarbazepine Metabolite2Product Code
- PTGTest, Methadone, Over The Counter2Product Code
- PTHTest, Barbiturate, Over The Counter2Product Code
- PUXTest, Amphetamine, Employment And Insurance Testing, Exempt2Product Code
- PUYTest, Barbiturate, Employment And Insurance Testing, Exempt2Product Code
- PUZTest, Benzodiazepine, Employment And Insurance Testing, Exempt2Product Code
- PVATest, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt2Product Code
- PVBTest, Codeine, Employment And Insurance Testing, Exempt2Product Code
- PVDTest, Methamphetamine, Employment And Insurance Testing, Exempt2Product Code
- PVETest, Methadone, Employment And Insurance Testing, Exempt2Product Code
- PVFTest, Methaqualone, Employment And Insurance Testing, Exempt2Product Code
- PVGTest, Morphine, Employment And Insurance Testing, Exempt2Product Code
- PVHTest, Opiates, Employment And Insurance Testing, Exempt2Product Code
- PVITest, Propoxyphene, Employment And Insurance Testing, Exempt2Product Code
- PVJTest, Cannabinoid, Employment And Insurance Testing, Exempt2Product Code
- PVKTest, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt2Product Code
- QAWTest, Tricyclic Antidepressants, Over The Counter2Product Code
- QBFTest, Propoxyphene, Over The Counter2Product Code
- QBKMeprobamate Test System2Product Code
- 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
Devices, Breath Trapping, Alcohol
- Page Type
- Product Code
- Regulation Medical Specialty
- Toxicology
- Review Panel
- Toxicology
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 862.3050
- 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
CFR § 862.3050 Breath-alcohol test system
§ 862.3050 Breath-alcohol test system.
(a) Identification. A breath-alcohol test system is a device intened to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
(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 the limitations in § 862.9.
[52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019]