FDA UDI
In Commercial Distribution
🇺🇸 United States
New Life Diagnostics
DI: 00850078606044
·
Model: Echinococcus IgG ELISA Kit
·
NEW LIFE DIAGNOSTICS LLC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- New Life Diagnostics
- Primary DI
- 00850078606044
- Version / Model
- Echinococcus IgG ELISA Kit
- Catalog Number
- 5005
- Company Name
- NEW LIFE DIAGNOSTICS LLC
- Labeler DUNS
- 081986839
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-13
- Public Version
- 1
- Public Version Date
- 2026-04-21
- Public Version Status
- New
- Public Device Record Key
- 55989eb1-4003-4313-a288-1428bf34c515
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 |
|---|---|---|---|---|
| 52219 | Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Echinococcus granulosus and/or Echinococcus multilocularis in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with the parasitic tapeworms associated with hydatid disease. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850078606044 | GS1 |