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PreKnow

FDA UDI

Class II (US FDA UDI)

by Idun Solutions Llc

Identity

Trade Name
PreKnow FDA UDI
Generic Name
Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical FDA UDI
Device Name
PreKnow Instant 10 Panel Multi-Drug Test DipCard (BAR-BUP-BZO-COC-MET-MTD-OPI-OXY-TCA-THC) FDA UDI
Model / Reference
IDOA-3105 FDA UDI
Description
PreKnow Instant 10 Panel Multi-Drug Test DipCard (BAR-BUP-BZO-COC-MET-MTD-OPI-OXY-TCA-THC) FDA UDI

Identifiers

Primary DI / UDI-DI
00857275007186 FDA UDI
510(k) Number
K153050 FDA UDI
FDA Product Code
LDJ FDA UDI
LFG FDA UDI
DNK FDA UDI
DJR FDA UDI
DJC FDA UDI
DIO FDA UDI
JXM FDA UDI
DJG FDA UDI
DIS FDA UDI
GMDN Term
Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3870 FDA UDI
862.3910 FDA UDI
862.3640 FDA UDI
862.3620 FDA UDI
862.3610 FDA UDI
862.3250 FDA UDI
862.3170 FDA UDI
862.3650 FDA UDI
862.3150 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 II — 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 fb495308-cfa1-4e49-b8b8-94110533883c 35 fields · synced May 29, 2026