FDA UDI
In Commercial Distribution
🇺🇸 United States
Monobind Qsure Anti-Tg & Anti-TPO Control Set
DI: 00816870020174
·
Model: AIT-101
·
MONOBIND, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Monobind Qsure Anti-Tg & Anti-TPO Control Set
- Primary DI
- 00816870020174
- Version / Model
- AIT-101
- Catalog Number
- AIT-101
- Company Name
- MONOBIND, INC.
- Labeler DUNS
- 083155515
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-11
- Public Version
- 4
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 13219f31-007f-4d46-b7c8-ee12729f0e2f
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| JJY | Multi-analyte controls, all kinds (assayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55211 | Multiple thyroid antibody IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antibodies to the thyroid gland and/or specific products of thyroid gland metabolism in a clinical specimen. Assayed antibodies include autoantibodies directed at antigens such as thyroid gland tissue, thyroglobulin, and thyroid peroxidase (TPO) [known as anti-microsomal antibody]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816870020174 | GS1 |
Customer Contacts
- Phone
- +1(949)951-2665
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 2 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Handling Environment Temperature
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius