Identity
- Trade Name
- Prime Screen FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Prime Screen® 1-Panel Card; 10 per box; COC Cocaine FDA UDI
- Model / Reference
- DWDCO-114-10BX-A FDA UDI
- Description
- Prime Screen® 1-Panel Card; 10 per box; COC Cocaine FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816862025996 FDA UDI
- 510(k) Number
- K202567 FDA UDI
- FDA Product Code
- NFY FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3250 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
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: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen by Wondfo Usa Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple drugs of abuse IVD, kit, rapid ICT, clinical.
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Cleared under the same submission
K202567 also covers:
- Easy@Home Multi-Drug Screen Test (1 test kit) — EASY HEALTHCARE CORPORATION
- iScreen™ — Instant Technologies, Inc.
- iScreen™ — Instant Technologies, Inc.
- iScreen™ — Instant Technologies, Inc.
- iScreen™ — Instant Technologies, Inc.
- iScreen™ — Instant Technologies, Inc.
- iScreen™ — Instant Technologies, Inc.
- iScreen™ — Instant Technologies, Inc.
- Prime Screen — WONDFO USA CO., LTD.
- Prime Screen — WONDFO USA CO., LTD.
- Prime Screen — WONDFO USA CO., LTD.
- Prime Screen — WONDFO USA CO., 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 II | Pending data |
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Manufacturer
- Manufacturer
- Wondfo Usa Co., Ltd.
Sources (1)
- FDA UDI 7cff5f72-c61a-48de-978f-2eb64e692532 36 fields · synced Jun 1, 2026