Identity
- Trade Name
- T-Dip FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- 6-Panel Card without THC; BUP,BZO,COC,MOP,MTD,OXY FDA UDI
- Model / Reference
- WDOA-865NT FDA UDI
- Description
- 6-Panel Card without THC; BUP,BZO,COC,MOP,MTD,OXY FDA UDI
Identifiers
- Catalog Number
- WDOA-865NT FDA UDI
- Primary DI / UDI-DI
- 00816862023657 FDA UDI
- 510(k) Number
- K202567 FDA UDI
- FDA Product Code
- NGL FDA UDINFV FDA UDINFY FDA UDIPTG FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3650 FDA UDI862.3170 FDA UDI862.3250 FDA UDI862.3620 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
Yes
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: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
T-Dip 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 00bc91c1-bc80-4c8b-b19d-3e1c42cae7bd 37 fields · synced May 30, 2026