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U.S. Department of Health and Human Services

Product Classification

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1 to 8 of 8 Results
510(K) Exempt Device Class 2 866.3165
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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
Sort by Device Class [0-9]
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GMD
antisera, latex agglutination, cryptococcus neofor ... Cryptococcus neoformans serological reag...
866.3165 2
GME
antisera, fluorescent, cryptococcus neoformans Cryptococcus neoformans serological reag...
866.3165 2
JWK
antigen, positive control, cryptococcus neoformans Cryptococcus neoformans serological reag...
866.3165 2
LHK
antigen, id, candida albicans Cryptococcus neoformans serological reag...
866.3165 2
LRF
candida spp., direct antigen, id Cryptococcus neoformans serological reag...
866.3165 2
LSG
candida species, antibody detection Cryptococcus neoformans serological reag...
866.3165 2
MDE
dna-probe, reagents, cryptococcal Cryptococcus neoformans serological reag...
866.3165 2
MDU
antigen, elisa, cryptococcus Cryptococcus neoformans serological reag...
866.3165 2
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