21 CFR 866.3305 — Antisera, Fluorescent, Herpesvirus Hominis 1,2
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3305
Identification
Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.
Classification Rationale
Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | 2 | 37 | |
| GQM | Antisera, Neutralization, Herpesvirus Hominis | 2 | 3 | |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 2 | 34 | |
| GQO | Antisera, Cf, Herpesvirus Hominis 1,2 | 2 | 16 | |
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 | 38 | |
| LKC | Antigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus | 2 | 0 | |
| MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | 20 | |
| MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 2 | 10 | |
| OQO | Herpes Simplex Virus Nucleic Acid Amplification Assay | 2 | 12 |
Special Controls
GQL — Antisera, Fluorescent, Herpesvirus Hominis 1,2
*Classification.* Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
eCFR
GQL — Antisera, Fluorescent, Herpesvirus Hominis 1,2
The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
Ecfr Llm
GQM — Antisera, Neutralization, Herpesvirus Hominis
*Classification.* Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
eCFR
GQN — Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
*Classification.* Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
eCFR
GQO — Antisera, Cf, Herpesvirus Hominis 1,2
*Classification.* Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
eCFR
LGC — Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
*Classification.* Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
eCFR
LKC — Antigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus
*Classification.* Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
eCFR
MXJ — Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
*Classification.* Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
eCFR
MYF — Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
*Classification.* Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
eCFR
OQO — Herpes Simplex Virus Nucleic Acid Amplification Assay
*Classification.* Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
eCFR
