Identity
- Trade Name
- Adrenocorticotropic Hormone ELISA FDA UDI
- Generic Name
- Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Adrenocorticotropic Hormone ELISA is intended for use in the quantitative determination of ACTH (Adrenocorticotropic Hormone) in human EDTA plasma. FDA UDI
- Model / Reference
- 21-ACTHU-E01 FDA UDI
- Description
- The Adrenocorticotropic Hormone ELISA is intended for use in the quantitative determination of ACTH (Adrenocorticotropic Hormone) in human EDTA plasma. FDA UDI
Identifiers
- Catalog Number
- 21-ACTHU-E01 FDA UDI
- Primary DI / UDI-DI
- B24221ACTHUE010 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
No
FDA UDI
Category: Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA)
Adrenocorticotropic Hormone ELISA by American Laboratory Products Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA).
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- ACTH AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · Class II
- ACTH (Adrenocorticotropic Hormone) ELISA — DRG International, Inc. · Class II
- ACTH (Adrenocorticotropic Hormone) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · 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
- Manufacturer
- American Laboratory Products Company
Sources (1)
- FDA UDI 71f29a9f-b125-456f-a6ac-188ddc02e451 37 fields · synced May 30, 2026