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Fastect II Drug Screen Dipstick Test

FDA UDI

Class U (US FDA UDI)

by Ameditech Inc.

Identity

Trade Name
Fastect II Drug Screen Dipstick Test FDA UDI
Generic Name
Phencyclidine (PCP) IVD, kit, rapid ICT, clinical FDA UDI
Device Name
PCP25 single drug dipstick test FDA UDI
Model / Reference
MF17 FDA UDI
Description
PCP25 single drug dipstick test FDA UDI

Identifiers

Catalog Number
MF17 FDA UDI
Primary DI / UDI-DI
00816565020922 FDA UDI
510(k) Number
K022355 FDA UDI
FDA Product Code
LCM FDA UDI
GMDN Term
Phencyclidine (PCP) IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
U 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

Fastect II Drug Screen Dipstick Test 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 5bb6c6b8-b0c9-4b73-9015-f9e3fd558965 38 fields · synced Jun 8, 2026