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NexScreen Cup

FDA UDI

Class II (US FDA UDI)

by Nexscreen, Llc

Identity

Trade Name
NexScreen Cup FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
THC, COC, OPI, AMP, MET, PCP, BZO, BAR, MTD drugs of abuse test cup FDA UDI
Model / Reference
60925N FDA UDI
Description
THC, COC, OPI, AMP, MET, PCP, BZO, BAR, MTD drugs of abuse test cup FDA UDI

Identifiers

Catalog Number
60925N FDA UDI
Primary DI / UDI-DI
00858984006033 FDA UDI
510(k) Number
K063379 FDA UDI
FDA Product Code
DJR FDA UDI
DIS FDA UDI
JXM FDA UDI
LCM FDA UDI
DJC FDA UDI
DKZ FDA UDI
DJG FDA UDI
DIO FDA UDI
LDJ FDA UDI
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3620 FDA UDI
862.3150 FDA UDI
862.3170 FDA UDI
862.3610 FDA UDI
862.3100 FDA UDI
862.3650 FDA UDI
862.3250 FDA UDI
862.3870 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

NexScreen Cup by Nexscreen, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K063379 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nexscreen, Llc

Sources (1)

  • FDA UDI 702e6a87-1fde-47ed-afeb-326cb65aaeda 38 fields · synced May 30, 2026