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U.S. Department of Health and Human Services

Product Classification

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Product
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Regulation
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MYY
separator, semi-automated, blood component  
1
MZH
test, quantitative, for hla, non-diagnostic  
not classified
MZI
test, qualitative, for hla, non-diagnostic  
Unclassified
MZK
system, separation, hematopoietic stem cell  
3
NDV
test, ecarin clotting time (ect)  
HDE
OTQ
research use only/hematology devices  
not classified
OVG
magnetic cell selection system for cd34+ cells from hpc-apheresis used in treatment of acute myeloid...  
HDE
PBA
ecarin clotting time  
HDE
PCZ
investigational use only - immunology  
not classified
PDC
investigational use only - hematology  
not classified
PEP
molecular erythrocyte typing test  
3
PJF
illuminator system for blood products  
3
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
QCZ
mechanical and enzymatic autologous skin processor for cell suspension, with applicator  
3
QPW
reagents and transportation supplies, sodium citrate blood specimen collection tube  
not classified
QWY
mechanical and enzymatic autologous skin processor for cell suspension, for stable vitiligo, with ap...  
3
QZV
pediatric extracorporeal synthetic semipermeable membrane cartridge for acute kidney injury  
3
SCK
ldt, non-molecular antisera for rare rbc antigens when there is no alternative ivd  
not classified
LKB
pad, alcohol, device disinfectant  
Unclassified
LKK
pump, infusion, implanted, programmable  
3
LMQ
device, peritoneal access, subcutaneous, implanted  
3
LNY
catheter, percutaneous, long term, intraspinal  
3
LPZ
container, frozen donor tissue storage  
Unclassified
LSX
controller, closed-loop, blood-pressure  
3
LWE
bone marrow collection/transfusion kit  
2
MQT
pump, drug administration, closed loop  
3
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
KTJ
system, test, alpha-fetoprotein, ria  
3
LOK
kit, test, alpha-fetoprotein for neural tube defects  
3
LTQ
calibrator for alpha-fetoprotein in mid-pregnancy maternal serum  
3
MAN
assay, interleukin  
3
MJB
antigen, cancer 549  
3
MTF
total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer  
3
MTG
test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign con...  
3
MYZ
kit, test (donors), for bloodborne pathogen  
2
MZA
test, equipment, automated bloodborne pathogen  
not classified
MZE
test, donor, cmv  
2
MZL
kit, test, quality control for endotoxin  
not classified
NAF
antigen(complexed),prostate specific,(cpsa)  
3
NAH
system, test, tumor marker, for detection of bladder cancer  
3
NYQ
chromogenic in situ hybridization, nucleic acid amplification, her2/neu gene, breast cancer  
3
OAW
cancer monitoring test system, soluble mesothelin-related peptides, epithelioid/biphasic mesotheliom...  
HDE
OCB
rt-pcr multigene expression test, sentinel lymph node, cancer metastasis detection  
3
OTR
research use only/immunology devices  
not classified
OYA
p2psa  
3
OYM
prostrate cancer genes nucleic acid amplification test system  
3
OYY
leukemia translocation panel multiplex test  
not classified
PIL
test for periprosthetic joint infection  
not classified
QLC
interleukin 6  
not classified
QRF
multi-analyte test system with algorithmic analysis for detection of prostate cancer  
3
QWQ
assays to detect pre-existing antibodies to adeno-associated virus (aav) viral vectors  
3
PMI
fluorescence in situ hybridization, platelet-derived growth factor receptor, beta polypeptide (pdgfr...  
3
PNK
fluorescence in situ hybridization, chromosome 17p deletion (tp53)  
3
LQI
hepatitis delta serological reagents  
3
MAQ
kit, dna detection, human papillomavirus  
3
MHR
test, anti-tumor cell susceptibility  
3
MYL
assay,enzyme linked immunosorbent,parvovirus b19 igg  
3
MYM
assay,enzyme linked immunosorbent,parvovirus b19 igm  
3
NCD
test, immunity, cell mediated, mycobacterium tuberculosis  
3
NWY
test, qualitative, detection of dengue igm and igg antibodies  
not classified
OIH
yersinia spp. reagents  
Unclassified
OJN
mycobacterium tuberculosis, cell mediated immune response, enzyme-linked immunospot test  
3
OJO
enzyme linked immunosorbent assay for the detection of lipoarabinomannan antigen of mycobacteria  
not classified
ORL
whole blood pre-treatment t-cell enrichment reagent  
3
OTT
research use only/microbiology  
not classified
OYB
kit, rna detection, human papillomavirus  
3
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
QKP
coronavirus antigen detection test system.  
not classified
QLT
covid-19 multi-analyte respiratory panel nucleic acid devices  
not classified
QLW
covid-19 test home collection kit devices  
not classified
QMN
covid-19 multi-analyte antigen device  
not classified
QSH
coronavirus marker detection  
not classified

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