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11Pannel drug test cup

FDA UDI

Class U (US FDA UDI)

by Co-Innovation Biotech Co., Ltd

Identity

Trade Name
11Pannel drug test cup FDA UDI
Generic Name
Phencyclidine (PCP) IVD, kit, rapid ICT, clinical FDA UDI
Model / Reference
11Pannel drug test cup FDA UDI

Identifiers

Primary DI / UDI-DI
06970429841123 FDA UDI
510(k) Number
K153050 FDA UDI
FDA Product Code
LCM FDA UDI
DJR FDA UDI
DNK FDA UDI
DJC FDA UDI
DIO FDA UDI
JXM FDA UDI
DJG FDA UDI
DIS FDA UDI
DKZ FDA UDI
GMDN Term
Phencyclidine (PCP) IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
U FDA UDI
Regulation Number
862.3620 FDA UDI
862.3640 FDA UDI
862.3610 FDA UDI
862.3250 FDA UDI
862.3170 FDA UDI
862.3650 FDA UDI
862.3150 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

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

11Pannel drug test cup by Co-Innovation Biotech Co., Ltd — 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
Co-Innovation Biotech Co., Ltd

Sources (1)

  • FDA UDI f5cda88f-c5bd-4251-9e00-8d56ed605ad9 34 fields · synced May 30, 2026