Clinical Chemistry

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Code	Device name	Class	21 CFR	510(k) (3y)
LFP	Conductivity Rate, Urea Nitrogen	Class 2	21 CFR 862.1770	6
LFQ	Acid, Uric, Acid Reduction Of Ferric Ion	Class 1	21 CFR 862.1775	5
LFR	Glucose Dehydrogenase, Glucose	Class 2	21 CFR 862.1345	73
LFS	Radioreceptor Assay, Human Chorionic Gonadotropin	Class 2	21 CFR 862.1155
LIG	Radioassay, Intrinsic Factor Blocking Antibody	Class 2	21 CFR 862.1810	8
LNW	Paper, Obstetric Ph	Class 1	21 CFR 862.1550	4
LPS	Urinary Homocystine (Nonquantitative) Test System	Class 2	21 CFR 862.1377	29
LPT	System, Test, Urinary Methylmalonic Acid	Class 2	21 CFR 862.1509
LPW	System, Test, Oxalate	Class 1	21 CFR 862.1542	1
LTB	Cyclosporine Radioimmunoassay	Class 2	21 CFR 862.1235	1
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Spec	Class 1	21 CFR 862.2050	3
MAR	Cyclosporine And Metabolites Serum Assay	Class 2	21 CFR 862.1235
MGS	High Performance Liquid Chromatography For Cyclosporine	Class 2	21 CFR 862.1235
MGU	Fluorescence Polarization Immunoassay For Cyclosporine	Class 2	21 CFR 862.1235
MGV	Radioimmunoassay For Cyclosporine	Class 2	21 CFR 862.1235
MJX	Kit, Serological, Positive Control	Class 1	21 CFR 862.1660	7
MJY	Kit, Serological, Negative Control	Class 1	21 CFR 862.1660	1
MJZ	Kit, Direct Antigen, Positive Control	Class 1	21 CFR 862.1660	3
MKA	Kit, Direct Antigen, Negative Control	Class 1	21 CFR 862.1660
MKW	Cyclosporine	Class 2	21 CFR 862.1235	9
MLM	Enzyme Immunoassay, Tracrolimus	Class 2	21 CFR 862.1678	9
MMI	Immunoassay Method, Troponin Subunit	Class 2	21 CFR 862.1215	95
MPG	Urinary Carbohydrate Analysis Kit	Class 1	21 CFR 862.1505	1
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Class 1	21 CFR 862.1113	17
MRG	System, Test, Vitamin D	Class 2	21 CFR 862.1825	46
MRR	System, Test, Low Density, Lipoprotein	Class 1	21 CFR 862.1475	31
MRV	Drink, Glucose Tolerance	Class 2	21 CFR 862.1345	3
MSJ	Apolipoproteins	Class 1	21 CFR 862.1475	50
MSM	System, Test, Lipoprotein(A)	Class 1	21 CFR 862.1475
MYT	Biosensor, Immunoassay, Cpk Or Isoenzymes	Class 2	21 CFR 862.1215	3
MZU	System, Test, Sodium, Enzymatic Method	Class 2	21 CFR 862.1665	2
MZV	Test, System, Potassium, Enzymatic Method	Class 2	21 CFR 862.1600	4
NAK	System, Test, Biotinidase	Class 2	21 CFR 862.1118	5
NAL	Test, Immunoassay, Biosensor, Hcg	Class 2	21 CFR 862.1155	2
NAO	Test, Carbohydrate Deficient Transferrin	Class 1	21 CFR 862.1360	3
NAQ	Lipoprotein, High Density, Hdl, Over The Counter	Class 1	21 CFR 862.1175	2
NBC	Test, Natriuretic Peptide	Class 2	21 CFR 862.1117	45
NBW	System, Test, Blood Glucose, Over The Counter	Class 2	21 CFR 862.1345	510
NDR	Enzyme Immunoassay, Inhibin-A	Class 1	21 CFR 862.1260	1
NDY	Test, Cystatin C	Class 2	21 CFR 862.1225	22
NEO	System, Test, Osteocalcin	Class 2	21 CFR 862.1050	2
NFX	Test, Cholesterol, Total, Over The Counter	Class 1	21 CFR 862.1175	1
NFZ	Test, Creatinine, Over The Counter	Class 2	21 CFR 862.1225
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Class 1	21 CFR 862.1300	2
NGD	Test, Lactic Acid, Over The Counter	Class 1	21 CFR 862.1450
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Class 1	21 CFR 862.1485	6
NGJ	Test, Nitrite, Urinary, Non-Quantitative, Over The Counter	Class 1	21 CFR 862.1510	1
NGO	Test, Triglycerides, Over The Counter	Class 1	21 CFR 862.1705
NHG	Enzyme Immunoassay, Cortisol, Salivary	Class 2	21 CFR 862.1205	7
NJV	Test, Albumin Cobalt Binding	Class 2	21 CFR 862.1215	2
NQL	System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem M	Class 2	21 CFR 862.1055	5
NQM	Immunoassay For Detection Of Amniotic Fluid Protein(S).	Class 1	21 CFR 862.1550	2
NRH	System, Breath Measurement	Class 1	21 CFR 862.1820	4
NSU	Instrumentation For Clinical Multiplex Test Systems	Class 2	21 CFR 862.2570	13
NVV	Digital Image, Storage And Communications, Non-Diagnostic, Laboratory	Class 1	21 CFR 862.2100
OAM	Immunoassay, Insulin-Like Growth Factor Binding Protein-1	Class 1	21 CFR 862.1550	2
OHQ	Multi-Analyte Controls Unassayed	Class 1	21 CFR 862.1660
OLD	Internal Polymerase Chain Reaction Control, Not Assay Specific	Class 1	21 CFR 862.1660	1
OND	Osmolality Of Tears	Class 1	21 CFR 862.1540	1
OOI	Real Time Nucleic Acid Amplification System	Class 2	21 CFR 862.2570	14
OSX	Galectin-3 In Vitro Diagnostic Assay	Class 2	21 CFR 862.1117	2
OTA	Mass Spectrometer For Clinical Multiplex Test Systems	Class 2	21 CFR 862.2570
OUE	Micro Total Analysis Instrument System	Class 2	21 CFR 862.2570
OUL	Thermocycler, Generic	Class 1	21 CFR 862.2310
OVA	Complete Gene Expression Profiling Accessory Reagents	Class 2	21 CFR 862.2570	1
OYG	St2 Assay	Class 2	21 CFR 862.1117	1
OYJ	Dna Specimen Collection, Saliva	Class 2	21 CFR 862.1675	7
PCA	Dna Genetic Analyzer	Class 2	21 CFR 862.2570	1
PDJ	Hemoglobin A1c Test System	Class 2	21 CFR 862.1373	26
PDS	Amniotic Fluid Protein Immunoassay	Class 1	21 CFR 862.1550
PEG	Nucleic Acid Quantitation Kit	Class 1	21 CFR 862.2310
PER	Automated Pipetting, Diluting And Specimen Processing Workstations For	Class 1	21 CFR 862.2750	3
PFQ	Mmp-9 Test System	Class 1	21 CFR 862.1540	1
PFT	Reagents For Molecular Diagnostic Test Systems	Class 1	21 CFR 862.3800	1
PHG	Droplet Digital Pcr System	Class 2	21 CFR 862.2570
PHV	Continuous Glucose Monitor Retrospective Data Analysis Software	Class 1	21 CFR 862.2120	1
PIG	Acute Kidney Injury Test System	Class 2	21 CFR 862.1220	5
PJC	Newborn Screening Specimen Collection Paper	Class 2	21 CFR 862.1675	2
PJD	Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device	Class 2	21 CFR 862.1675	9
PJE	Blood/Plasma Collection Device For Dna Testing	Class 2	21 CFR 862.1675	8
PJT	Continuous Glucose Monitor Secondary Display	Class 2	21 CFR 862.1350	2
PKU	Insulin Pump Secondary Display	Class 2	21 CFR 862.1350
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)	Class 2	21 CFR 862.1675
PQO	Anti-Müllerian Hormone Test System	Class 2	21 CFR 862.1092	5
PQQ	Data Acquisition Software	Class 2	21 CFR 862.2570
PQT	Alpha-L-Iduronidase (Idua) Newborn Screening Test System	Class 2	21 CFR 862.1488
PQU	Alpha-D-Glucosidase (Gaa) Newborn Screening Test System	Class 2	21 CFR 862.1488
PQV	ß-Glucocerebrosidase (Gba) Newborn Screening Test System	Class 2	21 CFR 862.1488
PQW	Alpha-D-Galactosidase A (Gla) Newborn Screening Test System	Class 2	21 CFR 862.1488	3
PRJ	Capillary Blood Collection Device For Alternative Site Collection	Class 2	21 CFR 862.1675	2
PSL	25-Oh-Vitamin D Mass Spectrometry Test System	Class 2	21 CFR 862.1840	1
PSM	Refractometer For Donor Testing	Class 1	21 CFR 862.2800
PTC	Uric Acid Test System For At Home Prescription Use	Class 1	21 CFR 862.1775	3
PYP	Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test	Class 1	21 CFR 862.1475	1
PYV	Hospital Continuous Glucose Monitoring System	Class 2	21 CFR 862.1345
PZI	Prescription Use Blood Glucose Meter For Near-Patient Testing	Class 2	21 CFR 862.1345	14
QBJ	Integrated Continuous Glucose Monitoring System, Factory Calibrated	Class 2	21 CFR 862.1355	18
QBV	Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentra	Class 1	21 CFR 862.2050	2
QBZ	Automated Platform Consisting Of Software And Instrumentation For Pool	Class 1	21 CFR 862.2750
QCC	Insulin Pump Therapy Adjustment Calculator For Healthcare Professional	Class 2	21 CFR 862.1358	5
QCL	Acid-Sphingomyelinase (Asm) Newborn Screening Test System	Class 2	21 CFR 862.1488
QCM	ß-Galactocerebrosidase (Galc) Newborn Screening Test System	Class 2	21 CFR 862.1488
QDH	Menopause Test System	Class 2	21 CFR 862.1093	1
QDK	Integrated Continuous Glucose Monitoring System For Non-Intensive Diab	Class 2	21 CFR 862.1355	4
QDL	Integrated Continuous Glucose Monitoring System For Professional Retro	Class 2	21 CFR 862.1355	1
QEI	Breast Milk Macronutrients Test System	Class 2	21 CFR 862.1493	3
QFG	Alternate Controller Enabled Insulin Infusion Pump	Class 2	21 CFR 880.5730	28
QII	Integrated Continuous Glucose Monitoring System For Professional Direc	Class 2	21 CFR 862.1355	1
QJE	Muscular Dystrophy Newborn Screening Test	Class 2	21 CFR 862.1506	1
QJI	Interoperable Automated Glycemic Controller	Class 2	21 CFR 862.1356	22
QJS	Interoperable Automated Glycemic Controller, Insulin Suspend	Class 2	21 CFR 862.1356	1
QKE	Immunoassay, Pregnanediol Glucuronide, Over The Counter	Class 1	21 CFR 862.1620	1
QKT	Clozapine Test System	Class 2	21 CFR 862.3245	1
QLG	Integrated Continuous Glucose Monitoring System, Factory Calibrated, N	Class 2	21 CFR 862.1355	9
QMA	Blood Collection Device For Cell-Free Nucleic Acid	Class 2	21 CFR 862.1676	2
QQB	Prognostic Test For Assessment Of Liver Related Disease Progression	Class 2	21 CFR 862.1622	1
QRV	Setmelanotide Eligibility Gene Variant Detection System	Class 2	21 CFR 862.1164	1
QRX	Continuous Glucose Monitor Informed Insulin Dose Calculator	Class 2	21 CFR 862.1358	5
QWH	Prognostic Test For Development Or Progression Of Preeclampsia	Class 2	21 CFR 862.1602	2
QWZ	Prognostic Test For Assessment Of Chronic Kidney Disease Progression	Class 2	21 CFR 862.1223	1
QZG	Menstrual Blood Collection Device	Class 2	21 CFR 862.1675
SAF	Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monito	Class 2	21 CFR 862.1355	4
SBA	Integrated Continuous Glucose Monitoring System With Sensor Containing	Class 2	21 CFR 862.1357	2
SBH	Integrated Continuous Glucose Monitor For Non-Intensive Glucose Manage	Class 2	21 CFR 862.1355	3
SFO	Electrode Measurement, Drain Effluent Ph	Class 2	21 CFR 862.1120	1
SFU	Glucose Range Monitoring System	Class 2	21 CFR 862.1359	1
SHB	Creatinine Test System For At Home Prescription Use	Class 2	21 CFR 862.1225	1