Rickettsia typhi IgG ELISA Kit RTG-96K

GUDID B266RTG96K0

An ELISA format for measuring IgG antibody against typhus group Rickettsia

FULLER LABORATORIES

Multiple Rickettsia species (typhus group) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: B266RTG96K0
• NIH Device Record Key: d1e328bf-dde1-4b6c-95d8-d3e0d5a01da7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rickettsia typhi IgG ELISA Kit
• Version Model Number: N/A
• Catalog Number: RTG-96K
• Company DUNS: 859340390
• Company Name: FULLER LABORATORIES
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B266RTG96K0 [Primary]

FDA Product Code

• LSQ: Reagent, Rickettsia Serological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-10-31

Devices Manufactured by FULLER LABORATORIES

• B266RTG96K0 - Rickettsia typhi IgG ELISA Kit: 2019-11-08An ELISA format for measuring IgG antibody against typhus group Rickettsia
• B266RTG96K0 - Rickettsia typhi IgG ELISA Kit: 2019-11-08 An ELISA format for measuring IgG antibody against typhus group Rickettsia
• B266SFG96K0 - Spotted Fever Rickettsia IgG ELISA Kit: 2019-11-08 An EIA assay for spotted fever Rickettsiosis IgG levels