FDA UDI
In Commercial Distribution
🇺🇸 United States
Schistosoma mansoni IgG ELISA
DI: 04048474038729
·
Model: EIA-3872
·
DRG Instruments Gesellschaft mit beschränkter Haftung
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Schistosoma mansoni IgG ELISA
- Primary DI
- 04048474038729
- Version / Model
- EIA-3872
- Catalog Number
- EIA-3872
- Company Name
- DRG Instruments Gesellschaft mit beschränkter Haftung
- Labeler DUNS
- 317134468
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-31
- Public Version
- 1
- Public Version Date
- 2023-09-08
- Public Version Status
- New
- Public Device Record Key
- bda071b0-36e2-4df1-b3b6-84a401b5f496
Device Description
The Schistosoma mansoni IgG ELISA is intended for the qualitative determination of IgG class antibodies against Schistosoma mansoni in human serum or plasma (citrate, heparin).
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GNH | Antigen, Fluorescent Antibody Test, Schistosoma Mansoni | Microbiology | 866.3600 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52385 | Schistosoma mansoni 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 the parasitic flatworm Schistosoma mansoni 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 | 04048474038729 | GS1 |
Customer Contacts
- Phone
- 973-564-7555
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius