FDA UDI
In Commercial Distribution
🇺🇸 United States
Validate
DI: 00850011135372
·
Model: 908bc
·
Lgc Clinical Diagnostics, Inc.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Validate
- Primary DI
- 00850011135372
- Version / Model
- 908bc
- Company Name
- Lgc Clinical Diagnostics, Inc.
- Labeler DUNS
- 075886031
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-09
- Public Version
- 4
- Public Version Date
- 2024-02-05
- Public Version Status
- Update
- Public Device Record Key
- 1f126b13-984d-4e4f-a1a4-e09fdcf5ee59
Device Description
Validate THY2 IVD Control
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41711 | Thyroglobulin IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of thyroglobulin in a clinical specimen. | No | Active |
| 54399 | Multiple thyroid hormone uptake (T-uptake) 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 the unbound/free portion of the unbound/free portion of multiple proteins [e.g., thyroxine binding globulin (TBG), transthyretin and/or albumin] associated with thyroid hormone uptake, in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850011135372 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – -10 Degrees Celsius