Clinical Toxicology

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Code	Device name	Class	21 CFR	510(k) (3y)
LET	Fluorescent Immunoassay, Phenobarbital	Class 2	21 CFR 862.3660	8
LEW	Thin Layer Chromatography, Theophylline	Class 2	21 CFR 862.3880	1
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Class 2	21 CFR 862.3910	21
LFH	U.V. Spectrometry, Tricyclic Antidepressant Drugs	Class 2	21 CFR 862.3910	6
LFI	High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs	Class 2	21 CFR 862.3910	4
LFM	Enzyme Immunoassay, Digitoxin	Class 2	21 CFR 862.3300	20
LFN	Nephelometric Inhibition Immunoassay, Phenobarbital	Class 2	21 CFR 862.3660	5
LFO	Nephelometric Inhibition Immunoassay, Diphenylhydantoin	Class 2	21 CFR 862.3350	1
LFT	Fluorescent Immunoassay, Primidone	Class 2	21 CFR 862.3680	8
LFW	Fluorescence Polarization Immunoassay, Tobramycin	Class 2	21 CFR 862.3900	10
LGI	Fluorescence Polarization Immunoassay, Carbamazepine	Class 2	21 CFR 862.3645	3
LGJ	Fluorescence Polarization Immunoassay, Amibacin	Class 2	21 CFR 862.3035	3
LGQ	Fluorescence Polarization Immunoassay, Phenobarbital	Class 2	21 CFR 862.3660	12
LGR	Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)	Class 2	21 CFR 862.3350	15
LGS	Fluorescence Polarization Immunoassay, Theophylline	Class 2	21 CFR 862.3880	13
LPX	Radioceptor Assay, Neuroleptic Drugs	Class 2	21 CFR 862.3645
MKU	Enzyme Immunoassay, Nicotine And Nicotine Metabolites	Class 1	21 CFR 862.3220	7
MLK	Thin Layer Chromatography, Tricyclic Antidepressant Drugs	Class 2	21 CFR 862.3910	2
MOJ	Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)	Class 2	21 CFR 862.3350	3
MRS	Test System, Nicotine, Cotinine, Metabolites	Class 1	21 CFR 862.3220	3
MSL	System, Test, Topiramatee	Class 2	21 CFR 862.3350	1
MXA	System, Test, Breath Nitric Oxide	Class 2	21 CFR 862.3080	15
NDW	Assay, Porphyrin, Spectrophotometry, Lithium	Class 2	21 CFR 862.3560	7
NFT	Test, Amphetamine, Over The Counter	Class 2	21 CFR 862.3100	31
NFV	Test, Benzodiazepine, Over The Counter	Class 2	21 CFR 862.3170
NFW	Test, Cannabinoid, Over The Counter	Class 2	21 CFR 862.3870	4
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Class 2	21 CFR 862.3250
NGG	Test, Methamphetamine, Over The Counter	Class 2	21 CFR 862.3610	1
NGI	Test, Morphine, Over The Counter	Class 2	21 CFR 862.3640
NGL	Test, Opiates, Over The Counter	Class 2	21 CFR 862.3650	23
NRP	Sirolimus Test System	Class 2	21 CFR 862.3840	5
NTI	Drug Metabolizing Enzyme Genotyping Systems	Class 2	21 CFR 862.3360	11
NVI	Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease	Class 2	21 CFR 862.3100	1
NWM	Immunoassay, Anti-Seizure Drug	Class 2	21 CFR 862.3350	5
OAV	Mycophenolic Acid Test System	Class 2	21 CFR 862.3840	3
ODW	Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping S	Class 2	21 CFR 862.3360	6
OIC	Blood Alcohol Kit (Excludes Hiv Testing)	Class 2	21 CFR 862.3040
OIW	Software, Similarity Score Algorithm, Tissue Of Origin For Malignant T	Class 2	21 CFR 862.3100	4
ORA	Breast Milk-Alcohol Test System	Class 2	21 CFR 862.3040
ORH	Lamotrigine Assay	Class 2	21 CFR 862.3350	2
ORI	Levetiracetam Assay	Class 2	21 CFR 862.3350	2
OTF	Gabapentin Assay	Class 2	21 CFR 862.3350	1
OUF	Everolimus Immunoassay	Class 2	21 CFR 862.3840	2
PDY	Organophosphate Test System	Class 2	21 CFR 862.3652	1
POX	Enzyme Immunoassay, Oxcarbazepine Metabolite	Class 2	21 CFR 862.3645	1
PTG	Test, Methadone, Over The Counter	Class 2	21 CFR 862.3620
PTH	Test, Barbiturate, Over The Counter	Class 2	21 CFR 862.3150	1
PUJ	Voriconazole Test System	Class 2	21 CFR 862.3970	1
PUX	Test, Amphetamine, Employment And Insurance Testing, Exempt	Class 2	21 CFR 862.3100
PUY	Test, Barbiturate, Employment And Insurance Testing, Exempt	Class 2	21 CFR 862.3150
PUZ	Test, Benzodiazepine, Employment And Insurance Testing, Exempt	Class 2	21 CFR 862.3170
PVA	Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing	Class 2	21 CFR 862.3250
PVB	Test, Codeine, Employment And Insurance Testing, Exempt	Class 2	21 CFR 862.3270
PVC	Test, Lsd, Employment And Insurance Testing, Exempt	Class 2	21 CFR 862.3580
PVD	Test, Methamphetamine, Employment And Insurance Testing, Exempt	Class 2	21 CFR 862.3610
PVE	Test, Methadone, Employment And Insurance Testing, Exempt	Class 2	21 CFR 862.3620
PVF	Test, Methaqualone, Employment And Insurance Testing, Exempt	Class 2	21 CFR 862.3630
PVG	Test, Morphine, Employment And Insurance Testing, Exempt	Class 2	21 CFR 862.3640
PVH	Test, Opiates, Employment And Insurance Testing, Exempt	Class 2	21 CFR 862.3650
PVI	Test, Propoxyphene, Employment And Insurance Testing, Exempt	Class 2	21 CFR 862.3700
PVJ	Test, Cannabinoid, Employment And Insurance Testing, Exempt	Class 2	21 CFR 862.3870
PVK	Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing	Class 2	21 CFR 862.3910
QAW	Test, Tricyclic Antidepressants, Over The Counter	Class 2	21 CFR 862.3910
QBF	Test, Propoxyphene, Over The Counter	Class 2	21 CFR 862.3700	1
QBK	Meprobamate Test System	Class 2	21 CFR 862.3590	2
QDR	Plazomicin Test System, Immunoassay	Class 2	21 CFR 862.3460	1
QXT	Infliximab Test System	Class 2	21 CFR 862.3115	1
QYD	Adalimumab Assay	Class 2	21 CFR 862.3115	1