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Sure-Screen®

FDA UDI

Class II (US FDA UDI)

by Medtox Diagnostics, Inc.

Identity

Trade Name
SURE-SCREEN® FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
A qualitative one-step immunochromatographic test panel for the detection of Amphetamine, Cocaine, Methamphetamine, Opiates, Phencyclidine, and THC (cannabinoids) drugs and/or their metabolites in human urine. FDA UDI
Model / Reference
600715 FDA UDI
Description
A qualitative one-step immunochromatographic test panel for the detection of Amphetamine, Cocaine, Methamphetamine, Opiates, Phencyclidine, and THC (cannabinoids) drugs and/or their metabolites in human urine. FDA UDI

Identifiers

Primary DI / UDI-DI
00690286000391 FDA UDI
510(k) Number
K010226 FDA UDI
K050394 FDA UDI
FDA Product Code
DKZ FDA UDI
DJG FDA UDI
DJC FDA UDI
DIO FDA UDI
LDJ FDA UDI
LCM 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
862.3650 FDA UDI
862.3610 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

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

Sure-Screen® by Medtox Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K010226 also covers:

K050394 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtox Diagnostics, Inc.

Sources (1)

  • FDA UDI 00c0622d-8759-49ca-8d73-e05702958649 37 fields · synced Jun 8, 2026