Identity
- Trade Name
- PTH (Parathyroid) Intact ELISA FDA UDI
- Generic Name
- Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The PTH (Parathyroid) Intact ELISA is intended for the quantitative determination of Intact-PTH (Parathyroid Hormone) in human serum. FDA UDI
- Model / Reference
- EIA-3645 FDA UDI
- Description
- The PTH (Parathyroid) Intact ELISA is intended for the quantitative determination of Intact-PTH (Parathyroid Hormone) in human serum. FDA UDI
Identifiers
- Catalog Number
- EIA-3645 FDA UDI
- Primary DI / UDI-DI
- 04048474036459 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Category: Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA)
PTH (Parathyroid) Intact ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA).
- PTH Whole & Intact AccuLite VAST CLIA Test System - 96 Wells — MONOBIND, INC. · Class II
- PTH (Intact, 1-84) ELISA — American Laboratory Products Company · Class II
- PTH (Parathyroid) Intact ELISA — DRG International, Inc. · Class II
- PTH Intact AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · Class II
- PTH Whole & Intact AccuBind VAST ELISA Test System - 96 Wells — MONOBIND, INC. · Class II
- PTH Whole & Intact AccuBind VAST ELISA Test System - 192 Wells — MONOBIND, INC. · Class II
- PTH Intact AccuLite CLIA Test System - 192 Wells — MONOBIND, INC. · Class II
- PTH Whole & Intact AccuLite VAST CLIA Test System - 192 Wells — MONOBIND, INC. · Class II
Cleared under the same submission
K974306 also covers:
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
Sources (1)
- FDA UDI c0a728ea-338b-4fee-a639-1e3e3bb2ac1f 37 fields · synced May 31, 2026