FDA UDI Not in Commercial Distribution 🇺🇸 United States

MININEPH™ Human C3 Kit

DI: 05051700011341 · Model: ZK023.R · THE BINDING SITE GROUP LIMITED
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
MININEPH™ Human C3 Kit
Primary DI
05051700011341
Version / Model
ZK023.R
Company Name
THE BINDING SITE GROUP LIMITED
Labeler DUNS
347045614
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-24
Public Version
4
Public Version Date
2022-06-02
Public Version Status
Update
Public Device Record Key
5988996f-8547-4969-b1b8-98ea9352c1e3
Distribution End Date
2022-05-31

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

GMDN Terms

Code Name
53684 Complement components C3/C3c IVD, kit, nephelometry/turbidimetry

Identifiers

Type ID
Primary 05051700011341

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius