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QuickTox Drug Screen Dipcard

FDA UDI

Class U (US FDA UDI)

by Ameditech Inc.

Identity

Trade Name
QuickTox Drug Screen Dipcard FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
COC300/OPI2000/THC50/AMP1000/PCP25 Adulteration Screen for PH-SG-OX FDA UDI
Model / Reference
QT20A FDA UDI
Description
COC300/OPI2000/THC50/AMP1000/PCP25 Adulteration Screen for PH-SG-OX FDA UDI

Identifiers

Catalog Number
QT20A FDA UDI
Primary DI / UDI-DI
00816565021103 FDA UDI
510(k) Number
K022355 FDA UDI
FDA Product Code
LCM FDA UDI
DIO FDA UDI
DJG FDA UDI
LDJ FDA UDI
DKZ FDA UDI
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
U FDA UDI
Regulation Number
862.3250 FDA UDI
862.3650 FDA UDI
862.3870 FDA UDI
862.3100 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

QuickTox Drug Screen Dipcard by Ameditech Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K022355 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ameditech Inc.

Sources (1)

  • FDA UDI 8a614e94-ece0-444e-8500-559ff5584c98 38 fields · synced Jun 6, 2026