FDA UDI In Commercial Distribution 🇺🇸 United States

β2-Microglobin Kit (Latex-Enhanced Immunoturbidimetric Method)

DI: 06970291985215 · Model: None · Medicalsystem Biotechnology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
β2-Microglobin Kit (Latex-Enhanced Immunoturbidimetric Method)
Primary DI
06970291985215
Version / Model
None
Company Name
Medicalsystem Biotechnology Co., Ltd.
Labeler DUNS
545261989
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-03-07
Public Version
2
Public Version Date
2022-10-10
Public Version Status
Update
Public Device Record Key
46010ce7-6dd8-4238-bbe6-292e9ab4cbf4

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
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
JZG System, Test, Beta-2-Microglobulin Immunological

GMDN Terms

Code Name
53927 Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry

Identifiers

Type ID
Primary 06970291985215