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ProScreen

FDA UDI

Class II (US FDA UDI)

by Instant Technologies, Inc.

Identity

Trade Name
ProScreen FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
Drugs of Abuse Cup, CLIA Waived, AMP/COC/MET1000/OPI2000/THC with Cr, Ni, pH, Bl, S.G. FDA UDI
Model / Reference
PSCupA-5M-W FDA UDI
Description
Drugs of Abuse Cup, CLIA Waived, AMP/COC/MET1000/OPI2000/THC with Cr, Ni, pH, Bl, S.G. FDA UDI

Identifiers

Primary DI / UDI-DI
00817405020591 FDA UDI
510(k) Number
K052115 FDA UDI
FDA Product Code
DIO FDA UDI
LDJ FDA UDI
DJG FDA UDI
DKZ FDA UDI
DJC 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
862.3870 FDA UDI
862.3650 FDA UDI
862.3100 FDA UDI
862.3610 FDA UDI
Commercial Distribution
Not 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

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

ProScreen by Instant Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K052115 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Instant Technologies, Inc.

Sources (1)

  • FDA UDI 4ce90d51-9cb9-4077-a6df-a1f9ff921386 37 fields · synced Jun 1, 2026