LT Brucella Antisera Test Reagents

Basic Information

• Brand Name: LT Brucella Antisera Test Reagents
• Primary DI: 06974621793235
• Version / Model: BAT-A
• Company Name: Zhuhai Longtime Biological Technology Co., Ltd
• Labeler DUNS: 708328288
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-01
• Public Version: 1
• Public Version Date: 2023-08-09
• Public Version Status: New
• Public Device Record Key: bf2df005-0a43-4d8f-bc81-e5383cc11996

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GSM	Antisera, Fluorescent, Brucella Spp.	Microbiology	866.3085	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62366	Multiple Brucella species total antibody IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to multiple species of Brucella bacteria in a clinical specimen, using an agglutination method. It is commonly used for the detection of infection with or exposure to Bordetella bacteria which may include B. abortus and B. melitensis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06974621793235	GS1