Identity
- Trade Name
- Poly stat FDA UDI
- Generic Name
- Human chorionic gonadotropin alpha-subunit IVD, control FDA UDI
- Device Name
- Qualitative HCG Control FDA UDI
- Model / Reference
- HCG-POC FDA UDI
- Description
- Qualitative HCG Control FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855574005377 FDA UDI
- 510(k) Number
- K921206 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Human chorionic gonadotropin alpha-subunit 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
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: Human chorionic gonadotropin alpha-subunit IVD, control
Poly stat by Polymedco, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Human chorionic gonadotropin alpha-subunit IVD, control.
- Poly stat — POLYMEDCO, INC. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Polymedco, Inc.
Sources (1)
- FDA UDI 8040b475-e7a1-42ef-89b1-9fc838cef6ad 35 fields · synced Jun 1, 2026