Immunology

FDA medical specialty panel: Immunology. Product code prefix: IM.

8 companies · 29 devices
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29 devices

BOND MMR Antibody Panel (K213348)

Class Class II K213348 PZJ
2023-02-21

Quantia IgE (K214068)

Class Class II K214068 DGC
2023-02-21

Idylla MSI Test (K211181)

Class Class II K211181 PZJ
2023-02-27

Traumatic brain injury (TBI) test (K223602)

Class Class II K223602 QAT
2023-03-02

Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C (K203245)

Class Class II K203245 MMW
2023-05-04

Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF (K231348)

Class Class II K231348 QSE
2023-06-05

GlutenID Celiac Genetic Health Risk Test (K241456)

Class Class II K241456 PTA
2025-01-07

Tina-quant Lipoprotein(a) Gen.2 Molarity (K241220)

Class Class II K241220 DFC
2025-01-24

K-ASSAY CRP (Ver.2) (K242170)

Class Class II K242170 DCK
2025-04-18

NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow’s Milk (Bos taurus); NOVEOS Immunoassay Analyz (K242531)

Class Class II K242531 DHB
2025-04-23

Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) (K243776)

Class Class II K243776 MOB
2025-05-07

Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio (K242706)

Class Class II K242706 SET
2025-05-16

Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit (K250549)

Class Class II K250549 DFH
2025-05-23

APO-Easy Genotyping kit (DEN240032)

Class Class II DEN240032 SFC
2025-06-12

Atellica IM Thyroglobulin (Tg) (K242981)

Class Class II K242981 MSW
2025-06-20

Alegria Flash ENA Screen (K250408)

Class Class II K250408 LLL
2025-09-19

Francisella tularensis Real-time PCR assay (K252072)

Class Class II K252072 SGA
2025-09-30

Elecsys Phospho-Tau (181P) Plasma (K252163)

Class Class II K252163 SET
2025-10-08

ADVIA Centaur Anti-Thyroid Peroxidase II (K250250)

Class Class II K250250 JZO
2025-10-17

Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser (K250159)

Class Class II K250159 SGG
2025-10-17

Alegria Flash CTD Screen (K250666)

Class Class II K250666 LLL
2025-10-22

ADVIA Centaur Anti-Thyroglobulin II (aTgII) (K250816)

Class Class II K250816 JNL
2025-12-04

ADVIA Centaur Cytokeratin Fragment 21-1 (K250925)

Class Class II K250925 OVK
2025-12-16

Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay (K253358)

Class Class II K253358 DFH
2025-12-19
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