AccessGUDID - DEVICE: Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EP (06974849369281)

GUDID

Device Identifier (DI) Information

Brand Name: Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EP
Version or Model: 50 tests/kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Primary DI Number: 06974849369281
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 560300737 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NJR	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e8dcca5d-6d1c-420c-8ae8-c3412744648f
Public Version Date: December 14, 2022
Public Version Number: 1
DI Record Publish Date: December 06, 2022