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Intact PTH (Parathyroid Hormone) ELISA
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 7022
Identity
- Trade Name
- Intact PTH (Parathyroid Hormone) ELISA EUDAMEDIntact-PTH [Parathyroid Hormone] ELISA [Enzyme-Linked ImmunoSorbent Assay] FDA UDI
- Generic Name
- Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Intact PTH (Parathyroid Hormone) ELISA EUDAMEDThe 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 EUDAMEDFDA 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
- 00083059070224 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00083059070224 EUDAMED
- 510(k) Number
- K974306 FDA UDI
- FDA Product Code
- CEW FDA UDI
- EMDN Code
- W0102060312 PARATHYROID HORMONE INTACT EUDAMED
- GMDN Term
- Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1545 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
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 by Biomerica, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00083059070224 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Biomerica, Inc.
- EUDAMED SRN
- US-MF-000015772
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 7166f6a3-80ce-48c3-b373-04979fd04f90 61 fields · synced May 30, 2026
- FDA UDI b25fdc90-0bbf-4626-9a37-4025e15249ca 35 fields · synced May 30, 2026