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U.S. Department of Health and Human Services

Product Classification

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Product
Code
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Device
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Regulation
Number
sort by regulation number [0-9]
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Device
Class
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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
SFI
sensor, glucose, invasive, component of automated insulin delivery system  
3
SIB
tempo pilot eckm: early cardio-kidney-metabolic  
not classified
SIC
tempo pilot ckm: cardio-kidney-metabolic  
not classified
SID
tempo pilot msk: musculoskeletal  
not classified
SIE
tempo pilot bh: behavioral health  
not classified
SIO
test for esophageal varices  
3

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