FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ImmunoFA Toxoplasma IgG
DI: 00613745012001
·
Model: 800-1200
·
GenBio
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ImmunoFA Toxoplasma IgG
- Primary DI
- 00613745012001
- Version / Model
- 800-1200
- Catalog Number
- 1200
- Company Name
- GenBio
- Labeler DUNS
- 940425333
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2026-04-20
- Public Version Status
- Update
- Public Device Record Key
- df948836-8173-4aca-ad0a-1008ba188322
- Distribution End Date
- 2025-08-28
Device Description
The ImmunoFA Toxo IgG Test is an immunofluorescence test for the detection and titration of IgG antibodies to Toxoplasma gondii in human serum. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.
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
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GLZ | Antigens, If, Toxoplasma Gondii | Microbiology | 866.3780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52437 | Toxoplasma gondii immunoglobulin G (IgG) 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 G (IgG) 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 | 00613745012001 | GS1 |
Customer Contacts
- Phone
- 858-592-9300
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K803134 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 100 tests |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius