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U.S. Department of Health and Human Services

Product Classification

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Device enzyme linked immunoabsorbent assay, rubeola igg
Regulation Description Rubeola (measles) virus serological reagents.
Definition The qualitative detection of measles specific igg antibodies in serum or plasma.
Physical State IVD reagent kit
Technical Method antigens and antisera used for the detection of measles antibodies
Target Area Not applicable in vitro use
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLJB
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(K) Exempt
Regulation Number 866.3520
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Third Party Review Not Third Party Eligible
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