Clinical Toxicology

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Code	Device name	Class	21 CFR	510(k) (3y)
DIC	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method	Class 2	21 CFR 862.3040	33
DID	Bacillus Subtilis Microbiology Assay, Tobramycin	Class 2	21 CFR 862.3900	5
DIE	Heavy Metals Control Materials	Class 1	21 CFR 862.3280	5
DIF	Drug Mixture Control Materials	Class 1	21 CFR 862.3280	202
DIG	Cholinesterase Test Paper	Class 1	21 CFR 862.3240	1
DIH	Colorimetry, Cholinesterase	Class 1	21 CFR 862.3240	26
DIJ	Lead, Delta Amino Levulinic Acid	Class 2	21 CFR 862.3550	2
DIK	Thin Layer Chromatography, Quinine	Class 1	21 CFR 862.3750
DIL	Radioimmunoassay, Primidone	Class 2	21 CFR 862.3680
DIM	Gas Chromatography, Salicylate	Class 2	21 CFR 862.3830
DIN	Gas Chromatography, Cocaine	Class 2	21 CFR 862.3250
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Class 2	21 CFR 862.3250	145
DIP	Enzyme Immunoassay, Diphenylhydantoin	Class 2	21 CFR 862.3350	44
DIQ	Radioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep.	Class 2	21 CFR 862.3640
DIR	Free Radical Assay, Cocaine	Class 2	21 CFR 862.3250	1
DIS	Enzyme Immunoassay, Barbiturate	Class 2	21 CFR 862.3150	100
DIT	Thin Layer Chromatography, Amphetamine	Class 2	21 CFR 862.3100	4
DIW	Hemagglutination Inhibition, Methadone	Class 2	21 CFR 862.3620	4
DIX	Thin Layer Chromatography, Phenobarbital	Class 2	21 CFR 862.3660
DIY	Gas Chromatography, Ethosuximide	Class 2	21 CFR 862.3380	1
DIZ	Delayed Analysis, Alcohol	Class 2	21 CFR 862.3040
DJB	Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.	Class 2	21 CFR 862.3450	19
DJC	Thin Layer Chromatography, Methamphetamine	Class 2	21 CFR 862.3610	31
DJD	Enzyme Immunoassay, Primidone	Class 2	21 CFR 862.3680	8
DJE	Thin Layer Chromatography, Salicylate	Class 2	21 CFR 862.3830	1
DJF	Gas Chromatography, Opiates	Class 2	21 CFR 862.3650
DJG	Enzyme Immunoassay, Opiates	Class 2	21 CFR 862.3650	215
DJH	Gas Chromatography, Phenobarbital	Class 2	21 CFR 862.3660	1
DJI	Antiserum, Gentamicin	Class 2	21 CFR 862.3450	1
DJJ	Fluorometry, Morphine	Class 2	21 CFR 862.3640	1
DJK	Digitoxin Control Serum, Ria	Class 1	21 CFR 862.3280	1
DJL	Free Radical Assay, Amphetamine	Class 2	21 CFR 862.3100
DJN	Mercury Dithiazone, Colorimetry, Barbiturate	Class 2	21 CFR 862.3150	1
DJP	Radioimmunoassay, Amphetamine	Class 2	21 CFR 862.3100	9
DJQ	Test Reagents For Phenothiazine	Class 2	21 CFR 862.3670	1
DJR	Enzyme Immunoassay, Methadone	Class 2	21 CFR 862.3620	63
DJX	Radioimmunoassay, Ethosuximide	Class 2	21 CFR 862.3380
DJZ	Devices, Breath Trapping, Alcohol	Class 1	21 CFR 862.3050	28
DKA	Antiserum, Digoxin	Class 2	21 CFR 862.3320	3
DKB	Calibrators, Drug Mixture	Class 2	21 CFR 862.3200	94
DKC	Alcohol Control Materials	Class 1	21 CFR 862.3280	11
DKD	Bacillus Subtilis, Microbiological Assay, Gentamicin	Class 2	21 CFR 862.3450	2
DKE	Reagents, Test, Tetrahydrocannabinol	Class 2	21 CFR 862.3870	12
DKH	Gas Chromatography, Diphenylhydantoin	Class 2	21 CFR 862.3350	2
DKJ	Colorimetry, Salicylate	Class 2	21 CFR 862.3830	29
DKN	Radioimmunoassay, Barbiturate	Class 2	21 CFR 862.3150	4
DKP	Radioimmunoassay, Phenobarbital	Class 2	21 CFR 862.3660	3
DKQ	Antiserum, Digitoxin	Class 2	21 CFR 862.3300
DKR	Thin Layer Chromatography, Methadone	Class 2	21 CFR 862.3620
DKT	Free Radical Assay, Opiates	Class 2	21 CFR 862.3650
DKW	Test Reagents For Sulphanimide Derivatives	Class 1	21 CFR 862.3850
DKX	Thin Layer Chromatography, Barbiturate	Class 2	21 CFR 862.3150	2
DKZ	Enzyme Immunoassay, Amphetamine	Class 2	21 CFR 862.3100	225
DLA	Test Reagents For Methyl Alcohol	Class 2	21 CFR 862.3040
DLB	Radioimmunoassay, Lsd (125-I)	Class 2	21 CFR 862.3580	7
DLD	Thin Layer Chromatography, Codeine	Class 2	21 CFR 862.3270
DLE	Reagents, Test, Bromides	Class 2	21 CFR 862.3645
DLF	Enzyme Immunoassay, Ethosuximide	Class 2	21 CFR 862.3380	9
DLH	Gas Chromatography, Alcohol	Class 2	21 CFR 862.3040
DLI	Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase	Class 1	21 CFR 862.3240	6
DLJ	Calibrators, Drug Specific	Class 2	21 CFR 862.3200	123
DLN	Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)	Class 2	21 CFR 862.3250	4
DLP	Radioimmunoassay, Diphenylhydantoin	Class 2	21 CFR 862.3350	5
DLR	Hemagglutination Inhibition, Morphine	Class 2	21 CFR 862.3640	2
DLS	Gas Chromatograph, Alcohol (Dedicated Instruments)	Class 2	21 CFR 862.3040
DLT	Hemagglutination, Opiates	Class 2	21 CFR 862.3650	1
DLX	Hemagglutination Inhibition, Barbiturate	Class 2	21 CFR 862.3150
DLZ	Enzyme Immunoassay, Phenobarbital	Class 2	21 CFR 862.3660	35
DMB	Gas Chromatography, Methadone	Class 2	21 CFR 862.3620	1
DMF	Gas Liquid Chromatography, Barbiturate	Class 2	21 CFR 862.3150
DMI	Potassium Dichromate Specific Reagent For Alcohol	Class 2	21 CFR 862.3040	1
DMJ	Test Reagents For Ethyl Alcohol	Class 2	21 CFR 862.3040
DMK	Lead, Protoporphyrin, Fluorometric	Class 2	21 CFR 862.3550
DML	Nad-Nadh, Specific Reagent For Alcohol Enzyme Method	Class 2	21 CFR 862.3040	13
DMN	Thin Layer Chromatography, Cocaine	Class 2	21 CFR 862.3250	2
DMP	Digoxin Control Serum, Ria	Class 1	21 CFR 862.3280	4
DMQ	Gas Chromatography, Primidone	Class 2	21 CFR 862.3680
DMR	Solution, M-Nitrophenol, Specific Reagent For Cholinesterase	Class 1	21 CFR 862.3240	1
DMT	Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet	Class 2	21 CFR 862.3040	8
DMX	Liquid Chromatography, Salicylate	Class 2	21 CFR 862.3830
DMY	Gas Chromatography, Morphine	Class 2	21 CFR 862.3640	1
DNA	Radioimmunoassay, Morphine-Barbiturate (125-I), Goat Antibody	Class 2	21 CFR 862.3640
DNC	Strip, Paper, Salicylate	Class 2	21 CFR 862.3830
DND	Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep.	Class 2	21 CFR 862.3300	1
DNE	Atomic Absorption, Antimony	Class 1	21 CFR 862.3110
DNF	Liquid Chromatography, Ethosuximide	Class 2	21 CFR 862.3380
DNG	Free Radical, Benzoylecgnonine	Class 2	21 CFR 862.3250
DNI	Liquid Chromatography, Amphetamine	Class 2	21 CFR 862.3100	1
DNJ	Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.	Class 2	21 CFR 862.3320	2
DNK	Thin Layer Chromatography, Morphine	Class 2	21 CFR 862.3640	4
DNL	Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Se	Class 2	21 CFR 862.3320	8
DNN	Calibrators, Ethyl Alcohol	Class 2	21 CFR 862.3200	7
DNO	Hemagglutination Inhibition, Gentamicin	Class 2	21 CFR 862.3450	1
DNP	Thin Layer Chromatography, Ethosuximide	Class 2	21 CFR 862.3380	1
DNQ	Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Coated Tubes Sep.	Class 2	21 CFR 862.3320
DNS	Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Double Label Sep.	Class 2	21 CFR 862.3320
DNT	Liquid Chromatography, Methadone	Class 2	21 CFR 862.3620
DNW	Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Charcoal Sep.	Class 2	21 CFR 862.3300
DNX	Lead, Protoporphyrin Zinc Method, Fluorometric	Class 2	21 CFR 862.3550
DNZ	Atomic Absorption, Arsenic	Class 1	21 CFR 862.3120
DOA	Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resi	Class 2	21 CFR 862.3320	1
DOB	Radioimmunoassay, Digitoxin (3-H)	Class 2	21 CFR 862.3300
DOD	Gas Chromatography, Amphetamine	Class 2	21 CFR 862.3100	1
DOE	Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep	Class 2	21 CFR 862.3640	12
DOF	Lead, Atomic Absorption	Class 2	21 CFR 862.3550	6
DOG	Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glyco	Class 2	21 CFR 862.3320	5
DOH	Electrometry, Cholinesterase	Class 1	21 CFR 862.3240
DOJ	Potassium Dichromate, Alcohol	Class 2	21 CFR 862.3040	2
DOK	Free Radical Assay, Morphine	Class 2	21 CFR 862.3640	1
DOL	Free Radical Assay, Lsd	Class 2	21 CFR 862.3580
DOM	Thin Layer Chromatography, Benzoylecgnonine	Class 2	21 CFR 862.3250
DON	Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.	Class 2	21 CFR 862.3320	17
DOO	Liquid Chromatography, Phenobarbital	Class 2	21 CFR 862.3660
DOR	Radioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep.	Class 2	21 CFR 862.3320	1
DOS	Thin Layer Chromatography, Primidone	Class 2	21 CFR 862.3680
DOW	Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Coated Tube	Class 2	21 CFR 862.3300
DOX	Fluorometer, Lead (Dedicated Instruments)	Class 2	21 CFR 862.3550	4
DOY	Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.	Class 2	21 CFR 862.3320	5
DOZ	Liquid Chromatography, Diphenylhydantoin	Class 2	21 CFR 862.3350	1
DPB	Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.	Class 2	21 CFR 862.3320	10
DPD	Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal Sep.	Class 2	21 CFR 862.3320	1
DPE	Thin Layer Chromatography, Diphenylhydantoin	Class 2	21 CFR 862.3350	1
DPG	Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.	Class 2	21 CFR 862.3300	3
DPH	Mercury, Atomic Absorption	Class 1	21 CFR 862.3600	2
DPI	Radioimmunoassay, Digoxin (125-I), Bovine Antibody, Charcoal Sep.	Class 2	21 CFR 862.3320
DPJ	Radioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate	Class 2	21 CFR 862.3100	2
DPK	Liquid Chromatography, Morphine	Class 2	21 CFR 862.3640	2
DPL	Radioimmunoassay, Digitoxin (125-I), Bovine Antibody, Charcoal Sep.	Class 2	21 CFR 862.3300
DPN	Thin Layer Chromatography, Propoxyphene	Class 2	21 CFR 862.3700	1
DPO	Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.	Class 2	21 CFR 862.3320	14
DPP	Free Radical Assay, Methadone	Class 2	21 CFR 862.3620
DPQ	Liquid Chromatography, Primidone	Class 2	21 CFR 862.3680
JIH	Flame Photometry, Lithium	Class 2	21 CFR 862.3560	12
JII	Atomic Absorption, Lithium	Class 2	21 CFR 862.3560	3
JKQ	Gold Chloride (Colorimetric), Bromide	Class 2	21 CFR 862.3645
JKS	Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monox	Class 1	21 CFR 862.3220	8
JKT	Gas Chromatograph, Carbon-Monoxide	Class 1	21 CFR 862.3220	2
JXM	Enzyme Immunoassay, Benzodiazepine	Class 2	21 CFR 862.3170	90
JXN	Enzyme Immunoassay, Propoxyphene	Class 2	21 CFR 862.3700	22
JXO	Enzyme Immunoassay, Cocaine	Class 2	21 CFR 862.3250	6
KJI	Radioimmunoassay, Kanamycin	Class 2	21 CFR 862.3520	6
KLB	Radioimmunoassay, Tobramycin	Class 2	21 CFR 862.3900	23
KLN	Radioimmunoassay, Cocaine Metabolite	Class 2	21 CFR 862.3250	14
KLO	Enzymatic Radiochemical Assay, Gentamicin	Class 2	21 CFR 862.3450
KLP	Amikacin Serum Assay	Class 2	21 CFR 862.3035	4
KLQ	Radioimmunoassay, Amikacin	Class 2	21 CFR 862.3035	20
KLR	Enzyme Immunoassay, Lidocaine	Class 2	21 CFR 862.3555	17
KLS	Enzyme Immunoassay, Theophylline	Class 2	21 CFR 862.3880	71
KLT	Enzyme Immunoassay, Carbamazepine	Class 2	21 CFR 862.3645	56
KXS	Radioimmunoassay, Methaqualone	Class 2	21 CFR 862.3630	16
KXT	Enzyme Immunoassay, Digoxin	Class 2	21 CFR 862.3320	85
KZT	Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin	Class 2	21 CFR 862.3450	1
KZW	Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Kanamycin	Class 2	21 CFR 862.3520
KZX	Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin	Class 2	21 CFR 862.3900
KZY	High Pressure Liquid Chromatography, Barbiturate	Class 2	21 CFR 862.3150
KZZ	Gas Chromatography, Benzodiazepine	Class 2	21 CFR 862.3170
LAA	High Pressure Liquid Chromatography, Benzodiazepine	Class 2	21 CFR 862.3170	1
LAB	Thin Layer Chromatography, Benzodiazepine	Class 2	21 CFR 862.3170
LAC	High Pressure Liquid Chromatography, Cocaine And Cocaine Metabolites	Class 2	21 CFR 862.3250
LAD	Gas Chromatography, Codeine	Class 2	21 CFR 862.3270
LAE	High Pressure Liquid Chromatography, Codeine	Class 2	21 CFR 862.3270	2
LAF	Gas Chromatography, Methamphetamine	Class 2	21 CFR 862.3610	49
LAG	High Pressure Liquid Chromatography, Methamphetamine	Class 2	21 CFR 862.3610	4
LAH	High Pressure Liquid Chromatography, Opiates	Class 2	21 CFR 862.3650
LAI	Thin Layer Chromatography, Opiates	Class 2	21 CFR 862.3650	1
LAJ	Gas Chromatography, Propoxyphene	Class 2	21 CFR 862.3700
LAK	High Pressure Liquid Chromatography, Propoxyphene	Class 2	21 CFR 862.3700
LAL	Eas Chromatography, Quinine	Class 1	21 CFR 862.3750
LAM	High Pressure Liquid Chromatography, Quinine	Class 1	21 CFR 862.3750
LAN	Enzyme Immunoassay, N-Acetylprocainamide	Class 2	21 CFR 862.3320	21
LAR	Enzyme Immunoassay, Procainamide	Class 2	21 CFR 862.3320	25
LAS	Drug Specific Control Materials	Class 1	21 CFR 862.3280	83
LAT	Radioimmunoassay, Cannabinoid(S)	Class 2	21 CFR 862.3870	16
LAW	Theophylline Control Materials	Class 1	21 CFR 862.3280	4
LAX	Lidocaine Control Materials	Class 1	21 CFR 862.3280	1
LAY	Methotrexate Control Materials	Class 1	21 CFR 862.3280
LAZ	N-Acetylprocainamide Control Materials	Class 1	21 CFR 862.3280	4
LBA	Procainamide Control Materials	Class 1	21 CFR 862.3280	1
LBZ	Enzyme Immunoassay, Quinidine	Class 2	21 CFR 862.3320	27
LCA	Radioimmunoassay, Theophylline	Class 2	21 CFR 862.3880	5
LCD	Enzyme Immunoassay, Gentamicin	Class 2	21 CFR 862.3450	37
LCE	Radioimmunoassay, Netilmicin (I-125)	Class 2	21 CFR 862.3450	6
LCQ	Fluorescent Immunoassay Gentamicin	Class 2	21 CFR 862.3450	19
LCR	Fluorescent Immunoassay, Tobramycin	Class 2	21 CFR 862.3900	17
LCS	Radioimmunoassay, Digoxin (125-I)	Class 2	21 CFR 862.3320	15
LCT	Radioimmunoassay, Digoxin (3-H)	Class 2	21 CFR 862.3320
LCW	Radioimmunoassay, Digitoxin (125-I)	Class 2	21 CFR 862.3300	3
LCY	U.V. Spectrometry, Theophylline	Class 2	21 CFR 862.3880	3
LCZ	U.V. Spectrometry, Primidone	Class 2	21 CFR 862.3680
LDA	U.V. Spectrometry, Phenobarbital	Class 2	21 CFR 862.3660
LDB	U.V. Spectrometry, Carbamazepine	Class 2	21 CFR 862.3645
LDC	U.V. Spectrometry, Diphenylhydantoin	Class 2	21 CFR 862.3350
LDJ	Enzyme Immunoassay, Cannabinoids	Class 2	21 CFR 862.3870	150
LDN	Enzymatic Radiochemical Assay, Amikacin	Class 2	21 CFR 862.3035	3
LDO	Enzymatic Radiochemical Assay, Tobramycin	Class 2	21 CFR 862.3900	3
LDP	Colorimetry, Acetaminophen	Class 2	21 CFR 862.3030	37
LEG	Enzyme Immunoassay, Valproic Acid	Class 2	21 CFR 862.3645	35
LEH	Radioimmunoassay, Vancomycin	Class 2	21 CFR 862.3950	31
LER	Fluorescent Immunoassay, Theophylline	Class 2	21 CFR 862.3880	15
LES	Fluorescent Immunoassay, Diphenylhydantoin	Class 2	21 CFR 862.3350	7