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Prime Screen

FDA UDI

Class II (US FDA UDI)

by Wondfo Usa Co., Ltd.

Identity

Trade Name
Prime Screen FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
7-Panel T-Square with Indicator; 25 per box; AMP,COC,MET,OPI,OXY,PCP,THC FDA UDI
Model / Reference
DQODOA-376EUO-I-25BX-A FDA UDI
Description
7-Panel T-Square with Indicator; 25 per box; AMP,COC,MET,OPI,OXY,PCP,THC FDA UDI

Identifiers

Primary DI / UDI-DI
00816862023886 FDA UDI
FDA Product Code
PUX FDA UDI
PVA FDA UDI
PVD FDA UDI
PVH FDA UDI
PVJ FDA UDI
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3100 FDA UDI
862.3250 FDA UDI
862.3610 FDA UDI
862.3650 FDA UDI
862.3870 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: 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

Similar devices

Also classified as Multiple drugs of abuse IVD, kit, rapid ICT, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wondfo Usa Co., Ltd.

Sources (1)

  • FDA UDI cf61594e-30f4-46bf-9475-7b52f1d9e2f6 35 fields · synced May 31, 2026