Identity
- Trade Name
- DBC Glucagon ELISA FDA UDI
- Generic Name
- Glucagon IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- For the quantitative measurement of Glucagon in human EDTA plasma by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use. FDA UDI
- Model / Reference
- CAN-GLN-390 FDA UDI
- Description
- For the quantitative measurement of Glucagon in human EDTA plasma by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- CAN-GLN-390 FDA UDI
- Primary DI / UDI-DI
- B261CANGLN3900 FDA UDI
- FDA Product Code
- JME FDA UDI
- GMDN Term
- Glucagon IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1335 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glucagon IVD, kit, enzyme immunoassay (EIA)
DBC Glucagon ELISA by Diagnostics Biochem Canada Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Ansh Labs Glucagon ELISA — Ansh Labs, LLC
- Glucagon ELISA — American Laboratory Products Company · Class I
- MP Biomedicals LLC — MP BIOMEDICALS, LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Diagnostics Biochem Canada Inc
Sources (1)
- FDA UDI 69a3b2db-f85f-4578-9e67-ae791edd6c4d 36 fields · synced May 31, 2026