Identity
- Trade Name
- ACTH (Adrenocorticotropic Hormone) ELISA FDA UDI
- Generic Name
- Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The DRG ACTH ELISA is intended for the quantitative determination of ACTH (Adreno-corticotropic Hormone) in human plasma. FDA UDI
- Model / Reference
- EIA-3647 FDA UDI
- Description
- The DRG ACTH ELISA is intended for the quantitative determination of ACTH (Adreno-corticotropic Hormone) in human plasma. FDA UDI
Identifiers
- Catalog Number
- EIA-3647 FDA UDI
- Primary DI / UDI-DI
- 04048474036473 FDA UDI
- 510(k) Number
- K982608 FDA UDI
- FDA Product Code
- CKG FDA UDI
- GMDN Term
- Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1025 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: Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA)
ACTH (Adrenocorticotropic Hormone) ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA).
- Adrenocorticotropic Hormone ELISA — American Laboratory Products Company · Class II
- ACTH AccuLite CLIA Test System - 192 Wells — MONOBIND, INC. · Class II
- ACTH AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · Class II
- ACTH (Adrenocorticotropic Hormone) ELISA — DRG International, Inc. · Class II
- ACTH AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · Class II
Cleared under the same submission
K982608 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 78982777-2700-45d7-b579-aaa71334aff7 37 fields · synced Jun 1, 2026