Identity
- Trade Name
- AdexusDx hCG Control Set (unassayed) FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, control FDA UDI
- Device Name
- hCG Control Set (unassayed) FDA UDI
- Model / Reference
- 401.009 FDA UDI
- Description
- hCG Control Set (unassayed) FDA UDI
Identifiers
- Catalog Number
- 401.009 FDA UDI
- Primary DI / UDI-DI
- 00858022006230 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total human chorionic gonadotropin IVD, control
AdexusDx hCG Control Set (unassayed) by Nowdiagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Nowdiagnostics, Inc.
Sources (1)
- FDA UDI a6267b2c-a5c9-4b29-8c5e-78b8d641a88f 34 fields · synced May 29, 2026