FDA UDI
In Commercial Distribution
🇺🇸 United States
Glucagon - RIA
DI: 05400569003019
·
Model: RB310
·
Diasource Immunoassays S.A. SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Glucagon - RIA
- Primary DI
- 05400569003019
- Version / Model
- RB310
- Company Name
- Diasource Immunoassays S.A. SA
- Labeler DUNS
- 458777323
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-09
- Public Version
- 1
- Public Version Date
- 2020-01-17
- Public Version Status
- New
- Public Device Record Key
- c1c3c827-be37-48e1-beb0-a87c4b1bed6a
Device Description
Glucagon - RIA
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JME | RADIOIMMUNOASSAY, GLUCAGON | Clinical Chemistry | 862.1335 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57242 | Glucagon IVD, kit, enzyme immunohistochemistry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glucagon in a clinical specimen, using an enzyme immunohistochemistry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05400569003019 | GS1 |