FDA UDI
In Commercial Distribution
🇺🇸 United States
Access TSH (3rd IS)
DI: 15099590744373
·
Model: C28643
·
Beckman Coulter, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Access TSH (3rd IS)
- Primary DI
- 15099590744373
- Version / Model
- C28643
- Catalog Number
- C28643
- Company Name
- Beckman Coulter, Inc.
- Labeler DUNS
- 008254708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-31
- Public Version
- 2
- Public Version Date
- 2023-07-26
- Public Version Status
- Update
- Public Device Record Key
- c48f54f5-a023-4cbb-8ee5-83898c9de59c
Device Description
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. This assay is capable of providing 3rd generation TSH results.
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | Clinical Chemistry | 862.1690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54386 | Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the quantitative measurement of thyroid stimulating hormone (TSH) in a clinical specimen, using a chemiluminescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15099590744373 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221225 | 000 |