LT Brucella Antibody Test Kit (Microcolumn Gel Method)

Basic Information

• Brand Name: LT Brucella Antibody Test Kit (Microcolumn Gel Method)
• Primary DI: 06974621793396
• Version / Model: 96 tests /kit
• Company Name: Zhuhai Longtime Biological Technology Co., Ltd
• Labeler DUNS: 708328288
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-06
• Public Version: 1
• Public Version Date: 2025-06-16
• Public Version Status: New
• Public Device Record Key: d82181ef-6127-4fe6-8424-8ed2058bfb8d
• Distribution End Date: 2025-06-06

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
KSY	Boxes, View, Blood Grouping	Hematology	864.9185	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52738	Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination	A collection of immunoglobulins capable of binding to specific antigenic determinants and intended to be used together in testing a clinical specimen to determine the Rh phenotype (CcDEe) [RH:1,2,3,4,5] of red blood cells, using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16974621793393	GS1	box	1	Not in Commercial Distribution	2025-06-06
Primary	06974621793396	GS1