FDA UDI Not in Commercial Distribution 🇺🇸 United States

Human alpha 1 acid glycoprotein Kit for use on SPAPLUS

DI: 05051700016537 · Model: NK063.S · THE BINDING SITE GROUP LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Human alpha 1 acid glycoprotein Kit for use on SPAPLUS
Primary DI
05051700016537
Version / Model
NK063.S
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
3
Public Version Date
2024-01-10
Public Version Status
Update
Public Device Record Key
7556cae8-4410-4be6-9491-3616937cbca7
Distribution End Date
2023-09-30

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
Yes
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 05051700016537

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius