FDA UDI
In Commercial Distribution
🇺🇸 United States
ImmunoFA Toxoplasma Slides
DI: 00613745012070
·
Model: 800-1207
·
Genbio
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ImmunoFA Toxoplasma Slides
- Primary DI
- 00613745012070
- Version / Model
- 800-1207
- Catalog Number
- 1207
- Company Name
- Genbio
- Labeler DUNS
- 940425333
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 7ffd074c-f6b7-4714-bfe3-cad90c5f49b9
Device Description
For use with ImmunoFA Toxoplasma kits
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 |
|---|---|---|---|---|
| 52453 | Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to the parasitic protozoan Toxoplasma gondii in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00613745012070 | 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 slides, 10 tests per slide |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -70 – -20 Degrees Celsius