FDA UDI In Commercial Distribution 🇺🇸 United States

Optilite Alpha-1-Acid Glycoprotein Kit

DI: 05051700017633 · Model: NK063.OPT.A · THE BINDING SITE GROUP LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Optilite Alpha-1-Acid Glycoprotein Kit
Primary DI
05051700017633
Version / Model
NK063.OPT.A
Company Name
THE BINDING SITE GROUP LIMITED
Labeler DUNS
347045614
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-24
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
65db771c-bd20-4725-ae3e-6eb86da890cb

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

Product Codes

Code Name
LKL Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control

GMDN Terms

Code Name
53606 Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry

Identifiers

Type ID
Primary 05051700017633

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius