Identity
- Trade Name
- HYPERsensitive hTSH Calibrators FDA UDI
- Generic Name
- Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- The Access HYPERsensitive hTSH calibrators (BSA matrix) are intended to calibrate the Access HYPERsensitive hTSH assay for the quantitative determination of hTSH levels in human serum and plasma using the Access Immunoassay Systems. FDA UDI
- Model / Reference
- 33825 FDA UDI
- Description
- The Access HYPERsensitive hTSH calibrators (BSA matrix) are intended to calibrate the Access HYPERsensitive hTSH assay for the quantitative determination of hTSH levels in human serum and plasma using the Access Immunoassay Systems. FDA UDI
Identifiers
- Catalog Number
- 33825 FDA UDI
- Primary DI / UDI-DI
- 15099590575304 FDA UDI
- FDA Product Code
- JIS FDA UDI
- GMDN Term
- Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
HYPERsensitive hTSH Calibrators by Beckman Coulter, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter, Inc.
Sources (1)
- FDA UDI ded8b4ec-f05e-4fa7-a841-c98f65b7ec5e 34 fields · synced Jun 8, 2026