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Immunology devices

234 product codes reviewed by the Immunology panel. 3,546 510(k) clearances and 452 recalls in the FDA data, 80% of those recalls name a 510(k).

27510(k)s in 12 months

39recalls in 12 months

362recalls that name a 510(k)

Active product codes, Class II

Code	Device	Class	510(k)s, 12 mo	Recalls, 12 mo
DHB	System, Test, Radioallergosorbent (Rast) Immunological	2	7	14
SET	Immunoassay Blood Test For Amyloid Pathology Assessment	2	2	7
PFF	High Throughput Dna Sequence Analyzer	2	0	7
OUY	Trichomonas Vaginalis Nucleic Acid Amplification Test System	2	0	3
LLL	Extractable Antinuclear Antibody, Antigen And Control	2	2	0
LTJ	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	2	1	1
NXO	Calprotectin, Fecal	2	0	2
QVR	Multiplex Nucleic Acid Detection System For Biothreat Agents	2	2	0
DCN	System, Test, C-Reactive Protein	2	0	1
DFC	Lipoprotein, Low-Density, Antigen, Antiserum, Control	2	1	0
DFH	Kappa, Antigen, Antiserum, Control	2	1	0
JMG	Radioimmunoassay (Two-Site Solid Phase), Ferritin	2	0	1
JNL	Immunochemical, Thyroglobulin Autoantibody	2	1	0
JZO	System, Test, Thyroid Autoantibody	2	0	1
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	2	1	0
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	2	1	0
NIG	System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer	2	1	0
NQD	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	2	1	0
OBE	Anti-Ss-A 52 Autoantibodies	2	1	0
OVK	Cytokeratin Fragments 21-1 Eia Kit	2	1	0
PZJ	Lynch Syndrome Test System	2	1	0
QUE	Spinal Muscular Atrophy Newborn Screening Test System	2	1	0
SGA	Biothreat Microbial Agent Nucleic Acid Detection Test	2	1	0
SGW	Device To Detect Antibodies To Hepatitis D Virus	2	1	0