| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | 第 2 类 | 21 CFR 862.3040 | 33 |
| DID | Bacillus Subtilis Microbiology Assay, Tobramycin | 第 2 类 | 21 CFR 862.3900 | 5 |
| DIE | Heavy Metals Control Materials | 第 1 类 | 21 CFR 862.3280 | 5 |
| DIF | Drug Mixture Control Materials | 第 1 类 | 21 CFR 862.3280 | 202 |
| DIG | Cholinesterase Test Paper | 第 1 类 | 21 CFR 862.3240 | 1 |
| DIH | Colorimetry, Cholinesterase | 第 1 类 | 21 CFR 862.3240 | 26 |
| DIJ | Lead, Delta Amino Levulinic Acid | 第 2 类 | 21 CFR 862.3550 | 2 |
| DIK | Thin Layer Chromatography, Quinine | 第 1 类 | 21 CFR 862.3750 | |
| DIL | Radioimmunoassay, Primidone | 第 2 类 | 21 CFR 862.3680 | |
| DIM | Gas Chromatography, Salicylate | 第 2 类 | 21 CFR 862.3830 | |
| DIN | Gas Chromatography, Cocaine | 第 2 类 | 21 CFR 862.3250 | |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 第 2 类 | 21 CFR 862.3250 | 145 |
| DIP | Enzyme Immunoassay, Diphenylhydantoin | 第 2 类 | 21 CFR 862.3350 | 44 |
| DIQ | Radioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep. | 第 2 类 | 21 CFR 862.3640 | |
| DIR | Free Radical Assay, Cocaine | 第 2 类 | 21 CFR 862.3250 | 1 |
| DIS | Enzyme Immunoassay, Barbiturate | 第 2 类 | 21 CFR 862.3150 | 100 |
| DIT | Thin Layer Chromatography, Amphetamine | 第 2 类 | 21 CFR 862.3100 | 4 |
| DIW | Hemagglutination Inhibition, Methadone | 第 2 类 | 21 CFR 862.3620 | 4 |
| DIX | Thin Layer Chromatography, Phenobarbital | 第 2 类 | 21 CFR 862.3660 | |
| DIY | Gas Chromatography, Ethosuximide | 第 2 类 | 21 CFR 862.3380 | 1 |
| DIZ | Delayed Analysis, Alcohol | 第 2 类 | 21 CFR 862.3040 | |
| DJB | Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep. | 第 2 类 | 21 CFR 862.3450 | 19 |
| DJC | Thin Layer Chromatography, Methamphetamine | 第 2 类 | 21 CFR 862.3610 | 31 |
| DJD | Enzyme Immunoassay, Primidone | 第 2 类 | 21 CFR 862.3680 | 8 |
| DJE | Thin Layer Chromatography, Salicylate | 第 2 类 | 21 CFR 862.3830 | 1 |
| DJF | Gas Chromatography, Opiates | 第 2 类 | 21 CFR 862.3650 | |
| DJG | Enzyme Immunoassay, Opiates | 第 2 类 | 21 CFR 862.3650 | 215 |
| DJH | Gas Chromatography, Phenobarbital | 第 2 类 | 21 CFR 862.3660 | 1 |
| DJI | Antiserum, Gentamicin | 第 2 类 | 21 CFR 862.3450 | 1 |
| DJJ | Fluorometry, Morphine | 第 2 类 | 21 CFR 862.3640 | 1 |
| DJK | Digitoxin Control Serum, Ria | 第 1 类 | 21 CFR 862.3280 | 1 |
| DJL | Free Radical Assay, Amphetamine | 第 2 类 | 21 CFR 862.3100 | |
| DJN | Mercury Dithiazone, Colorimetry, Barbiturate | 第 2 类 | 21 CFR 862.3150 | 1 |
| DJP | Radioimmunoassay, Amphetamine | 第 2 类 | 21 CFR 862.3100 | 9 |
| DJQ | Test Reagents For Phenothiazine | 第 2 类 | 21 CFR 862.3670 | 1 |
| DJR | Enzyme Immunoassay, Methadone | 第 2 类 | 21 CFR 862.3620 | 63 |
| DJX | Radioimmunoassay, Ethosuximide | 第 2 类 | 21 CFR 862.3380 | |
| DJZ | Devices, Breath Trapping, Alcohol | 第 1 类 | 21 CFR 862.3050 | 28 |
| DKA | Antiserum, Digoxin | 第 2 类 | 21 CFR 862.3320 | 3 |
| DKB | Calibrators, Drug Mixture | 第 2 类 | 21 CFR 862.3200 | 94 |
| DKC | Alcohol Control Materials | 第 1 类 | 21 CFR 862.3280 | 11 |
| DKD | Bacillus Subtilis, Microbiological Assay, Gentamicin | 第 2 类 | 21 CFR 862.3450 | 2 |
| DKE | Reagents, Test, Tetrahydrocannabinol | 第 2 类 | 21 CFR 862.3870 | 12 |
| DKH | Gas Chromatography, Diphenylhydantoin | 第 2 类 | 21 CFR 862.3350 | 2 |
| DKJ | Colorimetry, Salicylate | 第 2 类 | 21 CFR 862.3830 | 29 |
| DKN | Radioimmunoassay, Barbiturate | 第 2 类 | 21 CFR 862.3150 | 4 |
| DKP | Radioimmunoassay, Phenobarbital | 第 2 类 | 21 CFR 862.3660 | 3 |
| DKQ | Antiserum, Digitoxin | 第 2 类 | 21 CFR 862.3300 | |
| DKR | Thin Layer Chromatography, Methadone | 第 2 类 | 21 CFR 862.3620 | |
| DKT | Free Radical Assay, Opiates | 第 2 类 | 21 CFR 862.3650 | |
| DKW | Test Reagents For Sulphanimide Derivatives | 第 1 类 | 21 CFR 862.3850 | |
| DKX | Thin Layer Chromatography, Barbiturate | 第 2 类 | 21 CFR 862.3150 | 2 |
| DKZ | Enzyme Immunoassay, Amphetamine | 第 2 类 | 21 CFR 862.3100 | 225 |
| DLA | Test Reagents For Methyl Alcohol | 第 2 类 | 21 CFR 862.3040 | |
| DLB | Radioimmunoassay, Lsd (125-I) | 第 2 类 | 21 CFR 862.3580 | 7 |
| DLD | Thin Layer Chromatography, Codeine | 第 2 类 | 21 CFR 862.3270 | |
| DLE | Reagents, Test, Bromides | 第 2 类 | 21 CFR 862.3645 | |
| DLF | Enzyme Immunoassay, Ethosuximide | 第 2 类 | 21 CFR 862.3380 | 9 |
| DLH | Gas Chromatography, Alcohol | 第 2 类 | 21 CFR 862.3040 | |
| DLI | Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase | 第 1 类 | 21 CFR 862.3240 | 6 |
| DLJ | Calibrators, Drug Specific | 第 2 类 | 21 CFR 862.3200 | 123 |
| DLN | Hemagglutination, Cocaine Metabolites (Benzoylecgnonine) | 第 2 类 | 21 CFR 862.3250 | 4 |
| DLP | Radioimmunoassay, Diphenylhydantoin | 第 2 类 | 21 CFR 862.3350 | 5 |
| DLR | Hemagglutination Inhibition, Morphine | 第 2 类 | 21 CFR 862.3640 | 2 |
| DLS | Gas Chromatograph, Alcohol (Dedicated Instruments) | 第 2 类 | 21 CFR 862.3040 | |
| DLT | Hemagglutination, Opiates | 第 2 类 | 21 CFR 862.3650 | 1 |
| DLX | Hemagglutination Inhibition, Barbiturate | 第 2 类 | 21 CFR 862.3150 | |
| DLZ | Enzyme Immunoassay, Phenobarbital | 第 2 类 | 21 CFR 862.3660 | 35 |
| DMB | Gas Chromatography, Methadone | 第 2 类 | 21 CFR 862.3620 | 1 |
| DMF | Gas Liquid Chromatography, Barbiturate | 第 2 类 | 21 CFR 862.3150 | |
| DMI | Potassium Dichromate Specific Reagent For Alcohol | 第 2 类 | 21 CFR 862.3040 | 1 |
| DMJ | Test Reagents For Ethyl Alcohol | 第 2 类 | 21 CFR 862.3040 | |
| DMK | Lead, Protoporphyrin, Fluorometric | 第 2 类 | 21 CFR 862.3550 | |
| DML | Nad-Nadh, Specific Reagent For Alcohol Enzyme Method | 第 2 类 | 21 CFR 862.3040 | 13 |
| DMN | Thin Layer Chromatography, Cocaine | 第 2 类 | 21 CFR 862.3250 | 2 |
| DMP | Digoxin Control Serum, Ria | 第 1 类 | 21 CFR 862.3280 | 4 |
| DMQ | Gas Chromatography, Primidone | 第 2 类 | 21 CFR 862.3680 | |
| DMR | Solution, M-Nitrophenol, Specific Reagent For Cholinesterase | 第 1 类 | 21 CFR 862.3240 | 1 |
| DMT | Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet | 第 2 类 | 21 CFR 862.3040 | 8 |
| DMX | Liquid Chromatography, Salicylate | 第 2 类 | 21 CFR 862.3830 | |
| DMY | Gas Chromatography, Morphine | 第 2 类 | 21 CFR 862.3640 | 1 |
| DNA | Radioimmunoassay, Morphine-Barbiturate (125-I), Goat Antibody | 第 2 类 | 21 CFR 862.3640 | |
| DNC | Strip, Paper, Salicylate | 第 2 类 | 21 CFR 862.3830 | |
| DND | Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep. | 第 2 类 | 21 CFR 862.3300 | 1 |
| DNE | Atomic Absorption, Antimony | 第 1 类 | 21 CFR 862.3110 | |
| DNF | Liquid Chromatography, Ethosuximide | 第 2 类 | 21 CFR 862.3380 | |
| DNG | Free Radical, Benzoylecgnonine | 第 2 类 | 21 CFR 862.3250 | |
| DNI | Liquid Chromatography, Amphetamine | 第 2 类 | 21 CFR 862.3100 | 1 |
| DNJ | Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep. | 第 2 类 | 21 CFR 862.3320 | 2 |
| DNK | Thin Layer Chromatography, Morphine | 第 2 类 | 21 CFR 862.3640 | 4 |
| DNL | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Se | 第 2 类 | 21 CFR 862.3320 | 8 |
| DNN | Calibrators, Ethyl Alcohol | 第 2 类 | 21 CFR 862.3200 | 7 |
| DNO | Hemagglutination Inhibition, Gentamicin | 第 2 类 | 21 CFR 862.3450 | 1 |
| DNP | Thin Layer Chromatography, Ethosuximide | 第 2 类 | 21 CFR 862.3380 | 1 |
| DNQ | Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Coated Tubes Sep. | 第 2 类 | 21 CFR 862.3320 | |
| DNS | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Double Label Sep. | 第 2 类 | 21 CFR 862.3320 | |
| DNT | Liquid Chromatography, Methadone | 第 2 类 | 21 CFR 862.3620 | |
| DNW | Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Charcoal Sep. | 第 2 类 | 21 CFR 862.3300 | |
| DNX | Lead, Protoporphyrin Zinc Method, Fluorometric | 第 2 类 | 21 CFR 862.3550 | |
| DNZ | Atomic Absorption, Arsenic | 第 1 类 | 21 CFR 862.3120 | |
| DOA | Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resi | 第 2 类 | 21 CFR 862.3320 | 1 |
| DOB | Radioimmunoassay, Digitoxin (3-H) | 第 2 类 | 21 CFR 862.3300 | |
| DOD | Gas Chromatography, Amphetamine | 第 2 类 | 21 CFR 862.3100 | 1 |
| DOE | Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep | 第 2 类 | 21 CFR 862.3640 | 12 |
| DOF | Lead, Atomic Absorption | 第 2 类 | 21 CFR 862.3550 | 6 |
| DOG | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glyco | 第 2 类 | 21 CFR 862.3320 | 5 |
| DOH | Electrometry, Cholinesterase | 第 1 类 | 21 CFR 862.3240 | |
| DOJ | Potassium Dichromate, Alcohol | 第 2 类 | 21 CFR 862.3040 | 2 |
| DOK | Free Radical Assay, Morphine | 第 2 类 | 21 CFR 862.3640 | 1 |
| DOL | Free Radical Assay, Lsd | 第 2 类 | 21 CFR 862.3580 | |
| DOM | Thin Layer Chromatography, Benzoylecgnonine | 第 2 类 | 21 CFR 862.3250 | |
| DON | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep. | 第 2 类 | 21 CFR 862.3320 | 17 |
| DOO | Liquid Chromatography, Phenobarbital | 第 2 类 | 21 CFR 862.3660 | |
| DOR | Radioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep. | 第 2 类 | 21 CFR 862.3320 | 1 |
| DOS | Thin Layer Chromatography, Primidone | 第 2 类 | 21 CFR 862.3680 | |
| DOW | Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Coated Tube | 第 2 类 | 21 CFR 862.3300 | |
| DOX | Fluorometer, Lead (Dedicated Instruments) | 第 2 类 | 21 CFR 862.3550 | 4 |
| DOY | Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. | 第 2 类 | 21 CFR 862.3320 | 5 |
| DOZ | Liquid Chromatography, Diphenylhydantoin | 第 2 类 | 21 CFR 862.3350 | 1 |
| DPB | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep. | 第 2 类 | 21 CFR 862.3320 | 10 |
| DPD | Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal Sep. | 第 2 类 | 21 CFR 862.3320 | 1 |
| DPE | Thin Layer Chromatography, Diphenylhydantoin | 第 2 类 | 21 CFR 862.3350 | 1 |
| DPG | Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep. | 第 2 类 | 21 CFR 862.3300 | 3 |
| DPH | Mercury, Atomic Absorption | 第 1 类 | 21 CFR 862.3600 | 2 |
| DPI | Radioimmunoassay, Digoxin (125-I), Bovine Antibody, Charcoal Sep. | 第 2 类 | 21 CFR 862.3320 | |
| DPJ | Radioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate | 第 2 类 | 21 CFR 862.3100 | 2 |
| DPK | Liquid Chromatography, Morphine | 第 2 类 | 21 CFR 862.3640 | 2 |
| DPL | Radioimmunoassay, Digitoxin (125-I), Bovine Antibody, Charcoal Sep. | 第 2 类 | 21 CFR 862.3300 | |
| DPN | Thin Layer Chromatography, Propoxyphene | 第 2 类 | 21 CFR 862.3700 | 1 |
| DPO | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep. | 第 2 类 | 21 CFR 862.3320 | 14 |
| DPP | Free Radical Assay, Methadone | 第 2 类 | 21 CFR 862.3620 | |
| DPQ | Liquid Chromatography, Primidone | 第 2 类 | 21 CFR 862.3680 | |
| JIH | Flame Photometry, Lithium | 第 2 类 | 21 CFR 862.3560 | 12 |
| JII | Atomic Absorption, Lithium | 第 2 类 | 21 CFR 862.3560 | 3 |
| JKQ | Gold Chloride (Colorimetric), Bromide | 第 2 类 | 21 CFR 862.3645 | |
| JKS | Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monox | 第 1 类 | 21 CFR 862.3220 | 8 |
| JKT | Gas Chromatograph, Carbon-Monoxide | 第 1 类 | 21 CFR 862.3220 | 2 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 第 2 类 | 21 CFR 862.3170 | 90 |
| JXN | Enzyme Immunoassay, Propoxyphene | 第 2 类 | 21 CFR 862.3700 | 22 |
| JXO | Enzyme Immunoassay, Cocaine | 第 2 类 | 21 CFR 862.3250 | 6 |
| KJI | Radioimmunoassay, Kanamycin | 第 2 类 | 21 CFR 862.3520 | 6 |
| KLB | Radioimmunoassay, Tobramycin | 第 2 类 | 21 CFR 862.3900 | 23 |
| KLN | Radioimmunoassay, Cocaine Metabolite | 第 2 类 | 21 CFR 862.3250 | 14 |
| KLO | Enzymatic Radiochemical Assay, Gentamicin | 第 2 类 | 21 CFR 862.3450 | |
| KLP | Amikacin Serum Assay | 第 2 类 | 21 CFR 862.3035 | 4 |
| KLQ | Radioimmunoassay, Amikacin | 第 2 类 | 21 CFR 862.3035 | 20 |
| KLR | Enzyme Immunoassay, Lidocaine | 第 2 类 | 21 CFR 862.3555 | 17 |
| KLS | Enzyme Immunoassay, Theophylline | 第 2 类 | 21 CFR 862.3880 | 71 |
| KLT | Enzyme Immunoassay, Carbamazepine | 第 2 类 | 21 CFR 862.3645 | 56 |
| KXS | Radioimmunoassay, Methaqualone | 第 2 类 | 21 CFR 862.3630 | 16 |
| KXT | Enzyme Immunoassay, Digoxin | 第 2 类 | 21 CFR 862.3320 | 85 |
| KZT | Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin | 第 2 类 | 21 CFR 862.3450 | 1 |
| KZW | Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Kanamycin | 第 2 类 | 21 CFR 862.3520 | |
| KZX | Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin | 第 2 类 | 21 CFR 862.3900 | |
| KZY | High Pressure Liquid Chromatography, Barbiturate | 第 2 类 | 21 CFR 862.3150 | |
| KZZ | Gas Chromatography, Benzodiazepine | 第 2 类 | 21 CFR 862.3170 | |
| LAA | High Pressure Liquid Chromatography, Benzodiazepine | 第 2 类 | 21 CFR 862.3170 | 1 |
| LAB | Thin Layer Chromatography, Benzodiazepine | 第 2 类 | 21 CFR 862.3170 | |
| LAC | High Pressure Liquid Chromatography, Cocaine And Cocaine Metabolites | 第 2 类 | 21 CFR 862.3250 | |
| LAD | Gas Chromatography, Codeine | 第 2 类 | 21 CFR 862.3270 | |
| LAE | High Pressure Liquid Chromatography, Codeine | 第 2 类 | 21 CFR 862.3270 | 2 |
| LAF | Gas Chromatography, Methamphetamine | 第 2 类 | 21 CFR 862.3610 | 49 |
| LAG | High Pressure Liquid Chromatography, Methamphetamine | 第 2 类 | 21 CFR 862.3610 | 4 |
| LAH | High Pressure Liquid Chromatography, Opiates | 第 2 类 | 21 CFR 862.3650 | |
| LAI | Thin Layer Chromatography, Opiates | 第 2 类 | 21 CFR 862.3650 | 1 |
| LAJ | Gas Chromatography, Propoxyphene | 第 2 类 | 21 CFR 862.3700 | |
| LAK | High Pressure Liquid Chromatography, Propoxyphene | 第 2 类 | 21 CFR 862.3700 | |
| LAL | Eas Chromatography, Quinine | 第 1 类 | 21 CFR 862.3750 | |
| LAM | High Pressure Liquid Chromatography, Quinine | 第 1 类 | 21 CFR 862.3750 | |
| LAN | Enzyme Immunoassay, N-Acetylprocainamide | 第 2 类 | 21 CFR 862.3320 | 21 |
| LAR | Enzyme Immunoassay, Procainamide | 第 2 类 | 21 CFR 862.3320 | 25 |
| LAS | Drug Specific Control Materials | 第 1 类 | 21 CFR 862.3280 | 83 |
| LAT | Radioimmunoassay, Cannabinoid(S) | 第 2 类 | 21 CFR 862.3870 | 16 |
| LAW | Theophylline Control Materials | 第 1 类 | 21 CFR 862.3280 | 4 |
| LAX | Lidocaine Control Materials | 第 1 类 | 21 CFR 862.3280 | 1 |
| LAY | Methotrexate Control Materials | 第 1 类 | 21 CFR 862.3280 | |
| LAZ | N-Acetylprocainamide Control Materials | 第 1 类 | 21 CFR 862.3280 | 4 |
| LBA | Procainamide Control Materials | 第 1 类 | 21 CFR 862.3280 | 1 |
| LBZ | Enzyme Immunoassay, Quinidine | 第 2 类 | 21 CFR 862.3320 | 27 |
| LCA | Radioimmunoassay, Theophylline | 第 2 类 | 21 CFR 862.3880 | 5 |
| LCD | Enzyme Immunoassay, Gentamicin | 第 2 类 | 21 CFR 862.3450 | 37 |
| LCE | Radioimmunoassay, Netilmicin (I-125) | 第 2 类 | 21 CFR 862.3450 | 6 |
| LCQ | Fluorescent Immunoassay Gentamicin | 第 2 类 | 21 CFR 862.3450 | 19 |
| LCR | Fluorescent Immunoassay, Tobramycin | 第 2 类 | 21 CFR 862.3900 | 17 |
| LCS | Radioimmunoassay, Digoxin (125-I) | 第 2 类 | 21 CFR 862.3320 | 15 |
| LCT | Radioimmunoassay, Digoxin (3-H) | 第 2 类 | 21 CFR 862.3320 | |
| LCW | Radioimmunoassay, Digitoxin (125-I) | 第 2 类 | 21 CFR 862.3300 | 3 |
| LCY | U.V. Spectrometry, Theophylline | 第 2 类 | 21 CFR 862.3880 | 3 |
| LCZ | U.V. Spectrometry, Primidone | 第 2 类 | 21 CFR 862.3680 | |
| LDA | U.V. Spectrometry, Phenobarbital | 第 2 类 | 21 CFR 862.3660 | |
| LDB | U.V. Spectrometry, Carbamazepine | 第 2 类 | 21 CFR 862.3645 | |
| LDC | U.V. Spectrometry, Diphenylhydantoin | 第 2 类 | 21 CFR 862.3350 | |
| LDJ | Enzyme Immunoassay, Cannabinoids | 第 2 类 | 21 CFR 862.3870 | 150 |
| LDN | Enzymatic Radiochemical Assay, Amikacin | 第 2 类 | 21 CFR 862.3035 | 3 |
| LDO | Enzymatic Radiochemical Assay, Tobramycin | 第 2 类 | 21 CFR 862.3900 | 3 |
| LDP | Colorimetry, Acetaminophen | 第 2 类 | 21 CFR 862.3030 | 37 |
| LEG | Enzyme Immunoassay, Valproic Acid | 第 2 类 | 21 CFR 862.3645 | 35 |
| LEH | Radioimmunoassay, Vancomycin | 第 2 类 | 21 CFR 862.3950 | 31 |
| LER | Fluorescent Immunoassay, Theophylline | 第 2 类 | 21 CFR 862.3880 | 15 |
| LES | Fluorescent Immunoassay, Diphenylhydantoin | 第 2 类 | 21 CFR 862.3350 | 7 |