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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
OPI, BAR, BZO, MTD, TCA, OXY drugs of abuse test cup (CLIA WAIVED) FDA UDI
Model / Reference
C-60611N FDA UDI
Description
OPI, BAR, BZO, MTD, TCA, OXY drugs of abuse test cup (CLIA WAIVED) FDA UDI

Identifiers

Catalog Number
C-60611N FDA UDI
Primary DI / UDI-DI
00858984006118 FDA UDI
510(k) Number
K082898 FDA UDI
FDA Product Code
DJG FDA UDI
LFG FDA UDI
DJR FDA UDI
NFV FDA UDI
DIS FDA UDI
NGL 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 UDI
862.3910 FDA UDI
862.3620 FDA UDI
862.3170 FDA UDI
862.3150 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

No

FDA UDI

Over-the-Counter

Yes

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

K082898 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 8c896645-0ae5-4139-b872-865fd8fa77ff 38 fields · synced May 30, 2026