Identity
- Trade Name
- ACTH [Adrenocorticotropic Hormone] ELISA FDA UDI
- Generic Name
- Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Biomerica ACTH ELISA is intended for the quantitative determination of ACTH (Adrenocorticotropic Hormone) in human plasma. This assay is intended for in vitro diagnostic use. FDA UDI
- Model / Reference
- 7023 FDA UDI
- Description
- The Biomerica ACTH ELISA is intended for the quantitative determination of ACTH (Adrenocorticotropic Hormone) in human plasma. This assay is intended for in vitro diagnostic use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08305900070231 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
- 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
ACTH [Adrenocorticotropic Hormone] ELISA by Biomerica, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Biomerica, Inc.
Sources (1)
- FDA UDI dd24682c-899e-4fa0-b3b7-7ba949d67747 36 fields · synced Jun 8, 2026