FDA UDI
In Commercial Distribution
🇺🇸 United States
IFA T. gondii IgM Test System
DI: 00845533001526
·
Model: FA8001M
·
ZEUS SCIENTIFIC, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IFA T. gondii IgM Test System
- Primary DI
- 00845533001526
- Version / Model
- FA8001M
- Catalog Number
- FA8001M
- Company Name
- ZEUS SCIENTIFIC, INC.
- Labeler DUNS
- 080953946
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- fe3c2ab2-5bff-49c2-8e55-c413e4e5ecfb
Device Description
The ZEUS IFA Toxoplasma gondii IgM Test System is an indirect fluorescent antibody assay designed for the presumptive qualitative detection of IgM antibodies to T. gondii in human serum and for the presumptive diagnosis of acute, recent, or reactive T. gondii infection. To adquately assess the patient’s serological status; testing must be performed in conjunction with an anti-T. gondii IgG antibody assay. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors. Performance characteristics have not been established for screening sera from prenatal women or newborns.
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52441 | Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the parasitic protozoan Toxoplasma gondii in a clinical specimen, using a fluorescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845533001526 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius