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Oratect Oral Fluid Drug Screen Device

FDA UDI

Class II (US FDA UDI)

by Ameditech Inc.

Identity

Trade Name
Oratect Oral Fluid Drug Screen Device FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
MET50/THC40/COC20/AMP50/OPI40/PCP10 FDA UDI
Model / Reference
HM15 FDA UDI
Description
MET50/THC40/COC20/AMP50/OPI40/PCP10 FDA UDI

Identifiers

Catalog Number
HM15 FDA UDI
Primary DI / UDI-DI
00816565020854 FDA UDI
510(k) Number
K103227 FDA UDI
FDA Product Code
DJC FDA UDI
LDJ FDA UDI
DIO FDA UDI
DKZ FDA UDI
DJG 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
862.3610 FDA UDI
862.3870 FDA UDI
862.3250 FDA UDI
862.3100 FDA UDI
862.3650 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

Oratect Oral Fluid Drug Screen Device by Ameditech Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K103227 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 0b955b34-a06c-44fd-b5c7-facf05317635 38 fields · synced May 30, 2026