FDA UDI
In Commercial Distribution
🇺🇸 United States
AFIAS TSH-VB
DI: 08806133005279
·
Model: AFIAS TSH-VB
·
Boditech Med Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
24
Basic Information
- Brand Name
- AFIAS TSH-VB
- Primary DI
- 08806133005279
- Version / Model
- AFIAS TSH-VB
- Catalog Number
- SMFP-58
- Company Name
- Boditech Med Inc.
- Labeler DUNS
- 689062203
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 24
- Record Status
- Published
- Publish Date
- 2017-11-06
- Public Version
- 4
- Public Version Date
- 2020-06-17
- Public Version Status
- Update
- Public Device Record Key
- 0d915ff1-b84f-4d5e-9cc6-eafd04ee2dba
Device Description
AFIAS TSH-VB, for use in conjunction with the AFIAS-6/VB Analyzer, is an immunofluorometric test systerm intended for in vitro diagnostic use at clinical laboratorues and POC sites for the quantitative measurement of thyroid stimulating hormone(TSH) levels in sodium-heparinized or EDTA venous whole blood samples. The test system is intended for the monitoring of TSH levels in euthyroid and hypothyroid indiciduals.
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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | Clinical Chemistry | 862.1690 | 2 |
| KHO | Fluorometer, For Clinical Use | Clinical Chemistry | 862.2560 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54387 | Thyroid stimulating hormone (TSH) 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 quantitative measurement of thyroid stimulating hormone (TSH) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08806133005279 | GS1 | ||||
| Unit of Use | 18806133005276 | GS1 |
Customer Contacts
- Phone
- 732-9180770
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170232 | 000 |