FDA UDI In Commercial Distribution 🇺🇸 United States

BIOER Automated Nucleic Acid Purification System

DI: 06973843220208 · Model: NPAs-9620 · Hangzhou Bioer Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
BIOER Automated Nucleic Acid Purification System
Primary DI
06973843220208
Version / Model
NPAs-9620
Company Name
Hangzhou Bioer Technology Co., Ltd.
Labeler DUNS
545256935
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-01-11
Public Version
1
Public Version Date
2023-01-19
Public Version Status
New
Public Device Record Key
4ca0d8bd-e29a-4163-9387-b635ad3fa4c2

Device Description

For the detail information, please refer to the IFU.

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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JJH Clinical Sample Concentrator

GMDN Terms

Code Name
60736 Nucleic acid sample preparation instrument IVD

Identifiers

Type ID
Primary 06973843220208