ClearanceBrief
Panels › Immunology

Immunology devices

234 product codes reviewed by the Immunology panel. 3,545 510(k) clearances and 452 recalls in the FDA data, 80% of those recalls name a 510(k).

26510(k)s in 12 months
39recalls in 12 months
362recalls that name a 510(k)

Codes with the most recalls

CodeDeviceAll time12 months
DHBSystem, Test, Radioallergosorbent (Rast) Immunological2714
CFNMethod, Nephelometric, Immunoglobulins (G, A, M)200
NIGSystem, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer190
JZOSystem, Test, Thyroid Autoantibody181
MOISystem, Test, Immunological, Antigen, Tumor180
PFFHigh Throughput Dna Sequence Analyzer187
DCKC-Reactive Protein, Antigen, Antiserum, And Control170
MIDSystem, Test, Anticardiolipin Immunological170
DHRSystem, Test, Rheumatoid Factor150
LKJAntinuclear Antibody, Antigen, Control130
LTKTest, Epithelial Ovarian Tumor-Associated Antigen (Ca125)130
DDRMyoglobin, Antigen, Antiserum, Control120
LTJProstate-Specific Antigen (Psa) For Management Of Prostate Cancers121
NOETest, System, Immunoassay, Lipoprotein-Associated Phospholipase A2120
MSWSystem, Test, Thyroglobulin100

Active product codes

CodeDeviceClass510(k)s, 12 moRecalls, 12 mo
DHBSystem, Test, Radioallergosorbent (Rast) Immunological2714
SETImmunoassay Blood Test For Amyloid Pathology Assessment227
PFFHigh Throughput Dna Sequence Analyzer207
OUYTrichomonas Vaginalis Nucleic Acid Amplification Test System203
DFQSperm, Antigen, Antiserum, Control102
LLLExtractable Antinuclear Antibody, Antigen And Control220
LTJProstate-Specific Antigen (Psa) For Management Of Prostate Cancers211
NXOCalprotectin, Fecal202
DCNSystem, Test, C-Reactive Protein201
DFCLipoprotein, Low-Density, Antigen, Antiserum, Control210
DFHKappa, Antigen, Antiserum, Control210
JMGRadioimmunoassay (Two-Site Solid Phase), Ferritin201
JNLImmunochemical, Thyroglobulin Autoantibody210
JZOSystem, Test, Thyroid Autoantibody201
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)210
MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)210
NIGSystem, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer210
NQDCardiac C-Reactive Protein, Antigen, Antiserum, And Control210
OBEAnti-Ss-A 52 Autoantibodies210
OVKCytokeratin Fragments 21-1 Eia Kit210
PZJLynch Syndrome Test System210
QUESpinal Muscular Atrophy Newborn Screening Test System210
QVRMultiplex Nucleic Acid Detection System For Biothreat Agents210
SGABiothreat Microbial Agent Nucleic Acid Detection Test210
SGWDevice To Detect Antibodies To Hepatitis D Virus210

Latest recalls in this panel

DateFirm and productCodeLinked 510(k)
Oct 30, 2026Illumina, Inc.
VeriSeq Onsite Server V2 REF: 20047000
Open, Classified		 PFFNone listed
Oct 30, 2026Illumina, Inc.
Illumina DRAGEN Server for NextSeq 550Dx REF: 20086130,
Open, Classified		 PFFNone listed
Oct 30, 2026Illumina, Inc.
NovaSeq 6000Dx Instrument REF: 20068232, FOR IN VITRO DIAGNOSTIC USE
Open, Classified		 PFFNone listed
Oct 30, 2026Illumina, Inc.
MiSeq Dx Instrument REF: DX-410-1001 / 15036706, FOR IN VITRO DIAGNOSTIC USE
Open, Classified		 PFFNone listed
Oct 30, 2026Illumina, Inc.
Nextseq 550Dx Instrument REF: 20005715, FOR IN VITRO DIAGNOSTIC USE
Open, Classified		 PFFNone listed
Oct 22, 2026Life Technologies Holdings Pte Ltd
Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer
Open, Classified		 PFFNone listed
Oct 2, 2026DRG International, Inc.
Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
Open, Classified		 DFQNone listed
Oct 1, 2026Siemens Healthcare Diagnostics, Inc.
Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
Open, Classified		 DCNK221119
Oct 1, 2026Illumina, Inc.
NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130
Open, Classified		 PFFNone listed
Feb 5, 2026Fujirebio Diagnostics, Inc.
Product Name: Lumipulse -Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse -Amyloid Plasma Controls: This quality control product can
Open, Classified		 SETK242706
Feb 5, 2026Fujirebio Diagnostics, Inc.
Product Name: Lumipulse G -Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product Description: Lumipulse G -Amyloid 1-42-N Plasma Calibrators: The -Amy
Open, Classified		 SETK242706
Feb 5, 2026Fujirebio Diagnostics, Inc.
Product Name: Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable Product Description: Lumipulse G -Amyloid 1-42-N Plasma Immunor
Open, Classified		 SETK242706
Feb 5, 2026Fujirebio Diagnostics, Inc.
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217 Plasma Controls: This quality control product can
Open, Classified		 SETK242706
Feb 5, 2026Fujirebio Diagnostics, Inc.
Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma con
Open, Classified		 SETK242706
Feb 5, 2026Fujirebio Diagnostics, Inc.
Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Immunoreaction Cartrid
Open, Classified		 SETK242706
Feb 5, 2026Fujirebio Diagnostics, Inc.
Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: Lumipulse G pTau217/-Amyloid 1-42 Plasma Ratio is an in
Open, Classified		 SETK242706
Feb 4, 2026Changchun Wancheng Bio-Electron Co., Ltd.
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
Open, Classified		 DFQNone listed
Jan 2, 2026Roche Diagnostics Operations, Inc.
The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretre
Open, Classified		 JZOK193313
Dec 1, 2025GET TESTED INTERNATIONAL AB
8 in 1 STI Test Kit
Open, Classified		 OUYNone listed
Dec 1, 2025GET TESTED INTERNATIONAL AB
3 in 1 STI Test
Open, Classified		 OUYNone listed
Dec 1, 2025GET TESTED INTERNATIONAL AB
2 in 1 Trichomonas / Gardnerella Test
Open, Classified		 OUYNone listed
Dec 1, 2025GET TESTED INTERNATIONAL AB
Pollen Allergy Test
Open, Classified		 DHBNone listed
Dec 1, 2025GET TESTED INTERNATIONAL AB
Pet Allergy Test
Open, Classified		 DHBNone listed
Dec 1, 2025GET TESTED INTERNATIONAL AB
Heavy Metals Test
Open, Classified		 JMGNone listed
Dec 1, 2025GET TESTED INTERNATIONAL AB
Food Intolerance Test Small
Open, Classified		 DHBNone listed

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