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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
Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical FDA UDI
Device Name
Rapid Multi-drug Test Cup FDA UDI
Model / Reference
Rapid Multi-drug Test FDA UDI
Description
Rapid Multi-drug Test Cup FDA UDI

Identifiers

Primary DI / UDI-DI
06970429841819 FDA UDI
510(k) Number
K153050 FDA UDI
FDA Product Code
JXM FDA UDI
DKZ FDA UDI
DIS FDA UDI
DJG FDA UDI
DIO FDA UDI
DJC FDA UDI
DNK FDA UDI
DJR FDA UDI
LCM FDA UDI
LFG FDA UDI
LDJ FDA UDI
PVH FDA UDI
JXN FDA UDI
GMDN Term
Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3170 FDA UDI
862.3100 FDA UDI
862.3150 FDA UDI
862.3650 FDA UDI
862.3250 FDA UDI
862.3610 FDA UDI
862.3640 FDA UDI
862.3620 FDA UDI
862.3910 FDA UDI
862.3870 FDA UDI
862.3700 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

Yes

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

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 022a785d-26e5-4a32-a933-d192f34e2dbc 35 fields · synced May 30, 2026