AccessGUDID - DEVICE: Real-time PCR System (06973342002473)

GUDID

Device Identifier (DI) Information

Brand Name: Real-time PCR System
Version or Model: STC-96A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Jiangsu Bioperfectus Technologies Co., Ltd.

Primary DI Number: 06973342002473
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 548535842 *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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
48032	Thermal cycler nucleic acid amplification instrument IVD, manual	An electrically-powered laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. The instrument may also isolate, extract and/or prepare nucleic acid from a clinical specimen prior to amplification and the characterization of amplified product may occur separately following the amplification process using electrophoresis genetic-based probes or other investigative methods. The device operates with technician involvement in most procedural steps.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NSU	Instrumentation For Clinical Multiplex Test Systems

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: 3a93905e-646b-4120-95a1-64008ff077a9
Public Version Date: February 10, 2023
Public Version Number: 1
DI Record Publish Date: February 02, 2023