FDA UDI
In Commercial Distribution
🇺🇸 United States
Ansh Labs Glucagon ELISA
DI: 00853592008158
·
Model: AL-157-i
·
Ansh Labs, LLC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Ansh Labs Glucagon ELISA
- Primary DI
- 00853592008158
- Version / Model
- AL-157-i
- Catalog Number
- AL-157-i
- Company Name
- Ansh Labs, LLC
- Labeler DUNS
- 057752914
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-01
- Public Version
- 1
- Public Version Date
- 2021-06-09
- Public Version Status
- New
- Public Device Record Key
- 59c8edf8-f222-4553-aa42-c691163c03f3
Device Description
The Glucagon Enzyme Linked Immunosorbent Assay (ELISA) kit provides materials for the quantitative measurement of Glucagon in human plasma and other biological fluids. This assay is intended for in vitro diagnostic use.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54195 | Glucagon IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucagon in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853592008158 | GS1 |
Customer Contacts
- Phone
- 2814040260
- [email protected]