FDA UDI In Commercial Distribution 🇺🇸 United States

DBC Glucagon ELISA

DI: B261CANGLN3900 · Model: CAN-GLN-390 · Diagnostics Biochem Canada Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
DBC Glucagon ELISA
Primary DI
B261CANGLN3900
Version / Model
CAN-GLN-390
Catalog Number
CAN-GLN-390
Company Name
Diagnostics Biochem Canada Inc
Labeler DUNS
207718438
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-10-10
Public Version
1
Public Version Date
2024-10-18
Public Version Status
New
Public Device Record Key
69a3b2db-f85f-4578-9e67-ae791edd6c4d

Device Description

For the quantitative measurement of Glucagon in human EDTA plasma by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use.

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
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JME Radioimmunoassay, Glucagon

GMDN Terms

Code Name
54195 Glucagon IVD, kit, enzyme immunoassay (EIA)

Identifiers

Type ID
Primary B261CANGLN3900

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius