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Intact-PTH [Parathyroid Hormone] ELISA [Enzyme-Linked ImmunoSorbent Assay]
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Intact-PTH [Parathyroid Hormone] ELISA [Enzyme-Linked ImmunoSorbent Assay] FDA UDI
- Generic Name
- Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Biomerica Intact-PTH ELISA is intended for the quantitative determination of Intact-PTH (Parathyroid Hormone) in human serum. This assay is intended for in vitro diagnostic use. FDA UDI
- Model / Reference
- 7022 FDA UDI
- Description
- The Biomerica Intact-PTH ELISA is intended for the quantitative determination of Intact-PTH (Parathyroid Hormone) in human serum. This assay is intended for in vitro diagnostic use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08305900070224 FDA UDI
- 510(k) Number
- K974306 FDA UDI
- FDA Product Code
- CEW FDA UDI
- GMDN Term
- Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1545 FDA UDI
- Commercial Distribution
- Not 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
No
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
Intact-PTH [Parathyroid Hormone] ELISA [Enzyme-Linked ImmunoSorbent Assay] by Biomerica, Inc. — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biomerica, Inc.
Sources (2)
- FDA UDI 74edd2fe-1b64-4124-870f-047c191c157b 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced May 29, 2026