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PreKnow

FDA UDI

Class U (US FDA UDI)

by Idun Solutions Llc

Identity

Trade Name
PreKnow FDA UDI
Generic Name
Phencyclidine (PCP) IVD, kit, rapid ICT, clinical FDA UDI
Device Name
PreKnow 5-Panel Instant Multi-Drug Screen Test Dip Card, THC-COC-OPI-AMP-PCP FDA UDI
Model / Reference
IDOA-756 FDA UDI
Description
PreKnow 5-Panel Instant Multi-Drug Screen Test Dip Card, THC-COC-OPI-AMP-PCP FDA UDI

Identifiers

Primary DI / UDI-DI
00857275007179 FDA UDI
510(k) Number
K153050 FDA UDI
FDA Product Code
LCM FDA UDI
DKZ FDA UDI
DNK FDA UDI
DIO FDA UDI
LDJ FDA UDI
GMDN Term
Phencyclidine (PCP) IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
U FDA UDI
Regulation Number
862.3100 FDA UDI
862.3640 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

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

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

PreKnow by Idun Solutions Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K153050 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Idun Solutions Llc

Sources (1)

  • FDA UDI 7815159c-862d-4e6c-b8c9-73bc2a76a3e1 35 fields · synced Jun 8, 2026