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U.S. Department of Health and Human Services

Product Classification
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Product
Code
sort by product code [a-z]
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Device
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Regulation
Number
sort by regulation number [0-9]
sort by regulation number [9-0]
Device
Class
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sort by device class [9-0]
PHK
test, cell mediated immune response, liver and small bowel transplant/transplantation  
not classified
SCE
ivd offered as ldt, first marketed before may 6, 2024, not modified beyond scope described in preamb...  
not classified
SCF
ldt, unmet need within an integrated healthcare system  
not classified
SCG
modified version of another manufacturer’s fda-authorized test within scope described in preamble to...  
not classified
SCH
ldt, approved by nys clep  
not classified
SCI
ivd offered as ldt, not an ldt or under a targeted enforcement discretion policy described in preamb...  
not classified
SCJ
ldt, not under a targeted enforcement discretion policy described in preamble to ldt final rule  
not classified
NAP
cardiac support mesh wrap  
not classified
PCW
implantable pulse generator, programmer and battery charger  
not classified
PCX
artificial chordae tendinae delivery system  
not classified
PKK
stent delivery system  
not classified
QLJ
patient monitor with independent remote display and operation  
not classified
QLL
left ventricular ejection fraction screening tool  
not classified
QLM
intensive care unit, respiratory failure and hemodynamic instability tool  
not classified
QLN
extracorporeal system for carbon dioxide removal for the treatment of covid-19  
not classified
QNY
remote or wearable patient monitoring device for drug induced qt prolongation monitoring  
not classified
QNZ
powered communication system for emergency use  
not classified
QOA
ppg sensor wearable for hypercoagulation detection and covid-19 screening  
not classified
QOC
temporary non-roller type left or right heart support blood pump  
not classified
QOD
extracorporeal circuit and accessories for long term respiratory cariodpulmonary failure  
not classified
NSJ
restoration, noble metal  
not classified
NSK
dentures, partial  
not classified
NSL
dentures, full  
not classified
NSM
restoration, resin  
not classified
NSN
restoration, resin, crown and bridge  
not classified
NSO
restoration, porcelain-fused-to-metal  
not classified
NSP
restoration, porcelain  
not classified
NSQ
restoration, base metal  
not classified
NSR
prosthesis, orthodontic  
not classified
NXJ
denture, cosmetic only  
not classified
PKJ
crown and bridge material, resin based  
not classified
OAA
aid, visual, for nausea  
not classified
OAQ
electronic media, hyperacusis  
not classified
QOO
ventilator tubing and accessories  
not classified
QOP
respiratory humidifier for emergency use  
not classified
QOS
continuous ventilator  
not classified
QOV
critical care ventilator  
not classified
QOX
multi-patient circuit connector  
not classified
GBL
catheter, ureteral, general & plastic surgery Urological catheter and accessories
876.5130 not classified
PFE
gastrointestinal liner system  
not classified
PIK
metabolic neuromodulation system  
not classified
QLO
immunoadsorption column for emergency use  
not classified
MTH
tray, leukocyte typing  
not classified
MTN
test, syphilis, treponemal  
not classified
MTO
software, management, microplate assay  
not classified
MTQ
software, blood virus applications  
not classified
MTS
vials, challenge, endotoxin  
not classified
MVW
kit, western blot, hiv-1  
not classified
MVX
antibody, monoclonal blocking, hiv-1  
not classified
MVY
monoclonal, hiv-1  
not classified
MWO
reagent, blood bank, quality control  
not classified
MYK
kit, cord blood collection  
not classified
MYS
device, ahf, automated cryoprecipitation  
not classified
MYW
irradiation, blood indicators  
not classified
MZH
test, quantitative, for hla, non-diagnostic  
not classified
OTQ
research use only/hematology devices  
not classified
PCZ
investigational use only - immunology  
not classified
PDC
investigational use only - hematology  
not classified
PZT
peripheral blood processing device for osteoarthritis  
not classified
PZU
bone marrow processing device for clinical use  
not classified
PZV
peripheral blood processing device for clinical use  
not classified
QBG
assay, oral direct thrombin inhibitor  
not classified
QPW
reagents and transportation supplies, sodium citrate blood specimen collection tube  
not classified
SCK
ldt, non-molecular antisera for rare rbc antigens when there is no alternative ivd  
not classified
PGO
anti-stick glass syringe  
not classified
POT
lockbox (export only)  
not classified
PWC
general wellness product  
not classified
QIX
system, transdermal delivery, cder or cber led  
not classified
QIY
nasal spray, systemic delivery, cder or cber led  
not classified
QIZ
material, implantable for controlled release, cder or cber led  
not classified
QKR
face mask within the scope of the face mask and barrier face covering enforcement policy or face mas...  
not classified
QKU
non-niosh-approved disposable filtering facepiece respirators (ffrs)  
not classified
QKY
decontamination systems for n95 respirators  
not classified
QLD
protective barrier enclosure  
not classified
QLE
protective barrier enclosure with negative pressure  
not classified
QMF
mask, surgical, eua authorized  
not classified
QOZ
barrier face covering within the scope of the face mask and barrier face covering enforcement policy  
not classified
QPK
eua faceshields  
not classified
QZT
gowns and other apparel  
not classified
MZA
test, equipment, automated bloodborne pathogen  
not classified
MZL
kit, test, quality control for endotoxin  
not classified
OTR
research use only/immunology devices  
not classified
OYY
leukemia translocation panel multiplex test  
not classified
PIL
test for periprosthetic joint infection  
not classified
QLC
interleukin 6  
not classified
NWY
test, qualitative, detection of dengue igm and igg antibodies  
not classified
OJO
enzyme linked immunosorbent assay for the detection of lipoarabinomannan antigen of mycobacteria  
not classified
OTT
research use only/microbiology  
not classified
PCY
investigational use only - microbiology  
not classified
POA
reagents, zika virus nucleic acid  
not classified
POG
reagents, ebola zaire virus (detected in the west africa outbreak in 2014) nucleic acid  
not classified
PYS
zika virus serological reagents (emergency use)  
not classified
QHV
multiple osteoarticular pathogen antigen kit  
not classified
QIM
bartonella spp. serological reagents  
not classified
QIN
babesia spp. serological reagents  
not classified
QIO
anaplasma spp. and ehrlichia spp. serological reagents  
not classified
QIP
rickettsia spp. (spotted fever group or typhus group) serological reagents  
not classified
QIQ
orientia spp. (scrub typhus) serological reagents  
not classified
QJR
reagents, 2019-novel coronavirus nucleic acid  
not classified
QKO
reagent, coronavirus serological  
not classified

*   The maximium 1000 devices meeting your search criteria returned. Please narrow your search.
 
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