21 CFR Subpart D - Serological Reagents

  1. § 866.3010 Acinetobacter calcoaceticus serological reagents.
  2. § 866.3020 Adenovirus serological reagents.
  3. § 866.3035 Arizona spp. serological reagents.
  4. § 866.3040 Aspergillus spp. serological reagents.
  5. § 866.3045 In vitro diagnostic device for Bacillus spp. detection.
  6. § 866.3050 Beta-glucan serological assays.
  7. § 866.3060 Blastomyces dermatitidis serological reagents.
  8. § 866.3065 Bordetella spp. serological reagents.
  9. § 866.3085 Brucella spp. serological reagents.
  10. § 866.3110 Campylobacter fetus serological reagents.
  11. § 866.3120 Chlamydia serological reagents.
  12. § 866.3125 Citrobacter spp. serological reagents.
  13. § 866.3130 Clostridium difficile toxin gene amplification assay.
  14. § 866.3135 Coccidioides immitis serological reagents.
  15. § 866.3140 Corynebacterium spp. serological reagents.
  16. § 866.3145 Coxsackievirus serological reagents.
  17. § 866.3165 Cryptococcus neoformans serological reagents.
  18. § 866.3175 Cytomegalovirus serological reagents.
  19. § 866.3200 Echinococcus spp. serological reagents.
  20. § 866.3205 Echovirus serological reagents.
  21. § 866.3210 Endotoxin assay.
  22. § 866.3215 Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.
  23. § 866.3220 Entamoeba histolytica serological reagents.
  24. § 866.3225 Enterovirus nucleic acid assay.
  25. § 866.3235 Epstein-Barr virus serological reagents.
  26. § 866.3240 Equine encephalomyelitis virus serological reagents.
  27. § 866.3250 Erysipelothrix rhusiopathiae serological reagents.
  28. § 866.3255 Escherichia coli serological reagents.
  29. § 866.3270 Flavobacterium spp. serological reagents.
  30. § 866.3280 Francisella tularensis serological reagents.
  31. § 866.3290 Gonococcal antibody test (GAT).
  32. § 866.3300 Haemophilus spp. serological reagents.
  33. § 866.3305 Herpes simplex virus serological assays.
  34. § 866.3309 Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel.
  35. § 866.3310 Hepatitis A virus (HAV) serological assays.
  36. § 866.3320 Histoplasma capsulatum serological reagents.
  37. § 866.3328 Influenza virus antigen detection test system.
  38. § 866.3330 Influenza virus serological reagents.
  39. § 866.3332 Reagents for detection of specific novel influenza A viruses.
  40. § 866.3336 John Cunningham Virus serological reagents.
  41. § 866.3340 Klebsiella spp. serological reagents.
  42. § 866.3350 Leptospira spp. serological reagents.
  43. § 866.3355 Listeria spp. serological reagents.
  44. § 866.3360 Lymphocytic choriomeningitis virus serological reagents.
  45. § 866.3361 Mass spectrometer system for clinical use for the identification of microorganisms.
  46. § 866.3365 Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
  47. § 866.3370 Mycobacterium tuberculosis immunofluorescent reagents.
  48. § 866.3372 Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens.
  49. § 866.3373 Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens.
  50. § 866.3375 Mycoplasma spp. serological reagents.
  51. § 866.3380 Mumps virus serological reagents.
  52. § 866.3390 Neisseria spp. direct serological test reagents.
  53. § 866.3395 Norovirus serological reagents.
  54. § 866.3400 Parainfluenza virus serological reagents.
  55. § 866.3402 Plasmodium species antigen detection assays.
  56. § 866.3405 Poliovirus serological reagents.
  57. § 866.3410 Proteus spp. (Weil-Felix) serological reagents.
  58. § 866.3415 Pseudomonas spp. serological reagents.
  59. § 866.3460 Rabiesvirus immunofluorescent reagents.
  60. § 866.3470 Reovirus serological reagents.
  61. § 866.3480 Respiratory syncytial virus serological reagents.
  62. § 866.3490 Rhinovirus serological reagents.
  63. § 866.3500 Rickettsia serological reagents.
  64. § 866.3510 Rubella virus serological reagents.
  65. § 866.3520 Rubeola (measles) virus serological reagents.
  66. § 866.3550 Salmonella spp. serological reagents.
  67. § 866.3600 Schistosoma spp. serological reagents.
  68. § 866.3630 Serratia spp. serological reagents.
  69. § 866.3660 Shigella spp. serological reagents.
  70. § 866.3680 Sporothrix schenckii serological reagents.
  71. § 866.3700 Staphylococcus aureus serological reagents.
  72. § 866.3720 Streptococcus spp. exoenzyme reagents.
  73. § 866.3740 Streptococcus spp. serological reagents.
  74. § 866.3780 Toxoplasma gondii serological reagents.
  75. § 866.3820 Treponema pallidum nontreponemal test reagents.
  76. § 866.3830 Treponema pallidum treponemal test reagents.
  77. § 866.3850 Trichinella spiralis serological reagents.
  78. § 866.3860 Trichomonas vaginalis nucleic acid assay.
  79. § 866.3870 Trypanosoma spp. serological reagents.
  80. § 866.3900 Varicella-zoster virus serological reagents.
  81. § 866.3920 Assayed quality control material for clinical microbiology assays.
  82. § 866.3930 Vibrio cholerae serological reagents.
  83. § 866.3940 West Nile virus serological reagents.
  84. § 866.3945 Dengue virus serological reagents.
  85. § 866.3946 Dengue virus nucleic acid amplification test reagents.
  86. § 866.3950 In vitro human immunodeficiency virus (HIV) drug resistance genotype assay.
  87. § 866.3955 Human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing technology.
  88. § 866.3960 Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens.
  89. § 866.3970 Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid.
  90. § 866.3980 Respiratory viral panel multiplex nucleic acid assay.
  91. § 866.3985 Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
  92. § 866.3990 Gastrointestinal microorganism multiplex nucleic acid-based assay.