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Profile-Ii Er®

FDA UDI

Class II (US FDA UDI)

by Medtox Diagnostics, Inc.

Identity

Trade Name
PROFILE-II ER® 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 Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Tricyclic Antidepressants, Barbiturates, Methadone, Benzodiazepines, Propoxyphene (PPX), Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) and Oxycodone drugs and/or metabolites in human urine. FDA UDI
Model / Reference
601674 FDA UDI
Description
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Tricyclic Antidepressants, Barbiturates, Methadone, Benzodiazepines, Propoxyphene (PPX), Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) and Oxycodone drugs and/or metabolites in human urine. FDA UDI

Identifiers

Primary DI / UDI-DI
00690286000315 FDA UDI
510(k) Number
K002331 FDA UDI
K010226 FDA UDI
K020787 FDA UDI
K060351 FDA UDI
K982211 FDA UDI
FDA Product Code
JXN FDA UDI
DIS FDA UDI
DJR FDA UDI
LFG FDA UDI
JXM FDA UDI
DKZ FDA UDI
DJG FDA UDI
DJC FDA UDI
DIO FDA UDI
LCM FDA UDI
DKE FDA UDI
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3700 FDA UDI
862.3150 FDA UDI
862.3620 FDA UDI
862.3910 FDA UDI
862.3170 FDA UDI
862.3100 FDA UDI
862.3650 FDA UDI
862.3610 FDA UDI
862.3250 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

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

Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Profile-Ii Er® by Medtox Diagnostics, Inc. — 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.

Cleared under the same submission

K002331 also covers:

K010226 also covers:

K020787 also covers:

K060351 also covers:

K982211 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 8747b0a8-0785-4259-b614-8f6a274ebcac 36 fields · synced Jun 8, 2026