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U.S. Department of Health and Human Services

Product Classification

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1 to 9 of 9 Results
510(K) Exempt Device Class 1 866.3740
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Product
Code
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Device
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Regulation
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Sort by Regulation Number [9-0]
Device
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GTX
antisera, fluorescent, all groups, streptococcus s ... Streptococcus spp. serological reagents
866.3740 1
GTY
antigens, all groups, streptococcus spp. Streptococcus spp. serological reagents
866.3740 1
GTZ
antisera, all groups, streptococcus spp. Streptococcus spp. serological reagents
866.3740 1
GWB
antisera, fluorescent, all types, streptococcus pn ... Streptococcus spp. serological reagents
866.3740 1
GWC
antisera, all types, streptococcus pneumoniae Streptococcus spp. serological reagents
866.3740 1
MCT
dna-probe, strep pneumoniae Streptococcus spp. serological reagents
866.3740 1
MDK
dna-probe, reagents, streptococcal Streptococcus spp. serological reagents
866.3740 1
NJR
nucleic acid amplification assay system, group b s ... Streptococcus spp. serological reagents
866.3740 1
OAH
fish (fluorescent in situ hybridization) kit, prot ... Streptococcus spp. serological reagents
866.3740 1
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