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co-innovation

FDA UDI

Class II (US FDA UDI)

by Co-Innovation Biotech Co., Ltd

Identity

Trade Name
co-innovation FDA UDI
Generic Name
Methamphetamine-specific IVD, kit, rapid ICT, clinical FDA UDI
Device Name
12P Drug Test FDA UDI
Model / Reference
12P Drug Test FDA UDI
Description
12P Drug Test FDA UDI

Identifiers

Primary DI / UDI-DI
06970429841901 FDA UDI
510(k) Number
K153050 FDA UDI
FDA Product Code
DJG FDA UDI
JXW FDA UDI
DIO FDA UDI
DJC FDA UDI
DNK FDA UDI
LCM FDA UDI
LDJ FDA UDI
DIC FDA UDI
DJR FDA UDI
DKZ FDA UDI
GMDN Term
Methamphetamine-specific IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3650 FDA UDI
874.3540 FDA UDI
862.3250 FDA UDI
862.3610 FDA UDI
862.3640 FDA UDI
862.3870 FDA UDI
862.3040 FDA UDI
862.3620 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

No

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

co-innovation by Co-Innovation Biotech Co., Ltd — 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
Co-Innovation Biotech Co., Ltd

Sources (1)

  • FDA UDI f387e4a1-8dce-4064-b62f-535fb55d7367 35 fields · synced May 29, 2026