Identity
- Trade Name
- CARDINAL HEALTH FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, control FDA UDI
- Device Name
- hCG Controls; 1 Set; IVD FDA UDI
- Model / Reference
- B1077-24 FDA UDI
- Description
- hCG Controls; 1 Set; IVD FDA UDI
Identifiers
- Catalog Number
- B1077-24 FDA UDI
- Primary DI / UDI-DI
- 20885380020275 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
Yes
FDA UDI
Convenience Kit
No
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: Total human chorionic gonadotropin IVD, control
Cardinal Health by Cardinal Health 200, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Total human chorionic gonadotropin IVD, control.
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- Sure-Vue hCG Serum Control Set — SA SCIENTIFIC, LTD
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
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI e7dabdfe-68ed-4084-96fc-47f7eb752bb2 35 fields · synced Jun 8, 2026