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U.S. Department of Health and Human Services

Product Classification
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101 to 110 of 1000 results *
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Product
Code
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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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PDA
investigational use only - clinical chemistry  
not classified
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
SIB
tempo pilot eckm: early cardio-kidney-metabolic  
not classified
SIC
tempo pilot ckm: cardio-kidney-metabolic  
not classified

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