Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EP

Basic Information

• Brand Name: Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EP
• Primary DI: 06974849369281
• Version / Model: 50 tests/kit
• Company Name: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
• Labeler DUNS: 560300737
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-06
• Public Version: 1
• Public Version Date: 2022-12-14
• Public Version Status: New
• Public Device Record Key: e8dcca5d-6d1c-420c-8ae8-c3412744648f

Device Characteristics

• Single Use: No
• 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: Yes
• 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
NJR	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test	Microbiology	866.3740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51753	Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from Group B beta-haemolytic Streptococcus bacteria in a clinical specimen, using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06974849369281	GS1