FDA UDI
In Commercial Distribution
🇺🇸 United States
ELISA TPO IgG Smart Kit Test System
DI: 00845533001250
·
Model: SM2Z5051G
·
ZEUS SCIENTIFIC, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ELISA TPO IgG Smart Kit Test System
- Primary DI
- 00845533001250
- Version / Model
- SM2Z5051G
- Catalog Number
- SM2Z5051G
- 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
- 3
- Public Version Date
- 2024-02-16
- Public Version Status
- Update
- Public Device Record Key
- dc693906-db57-4548-97d8-17b0ec825f53
Device Description
The ZEUS ELISA Thyroid Peroxidase (TPO) IgG Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibodies to thyroid peroxidase (TPO) in human serum. The test system is intended to be used as an aid in the diagnosis of thyroid diseases. This test is for In Vitro diagnostic use.
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 |
|---|---|---|---|---|
| 55203 | Thyroid peroxidase antibody (anti-TPO/microsomal 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 antibodies to thyroid peroxidase [anti-TPO, also known as anti-microsomal antibody] in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis of chronic lymphocytic thyroiditis (also known as hashimoto thyroiditis). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845533001250 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius