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Nano-CheckTM DAT 5M

FDA UDI

by Nano-Ditech Corporation

Identity

Trade Name
Nano-CheckTM DAT 5M FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
In Vitro Diagnostic Test kit for the detection of muti-drug in human urine. FDA UDI
Model / Reference
AD508U FDA UDI
Description
In Vitro Diagnostic Test kit for the detection of muti-drug in human urine. FDA UDI

Identifiers

Catalog Number
AD508U FDA UDI
Primary DI / UDI-DI
00895160002533 FDA UDI
510(k) Number
K050594 FDA UDI
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI

Classification

Commercial Distribution
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

No

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

Yes

FDA UDI

Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Nano-CheckTM DAT 5M by Nano-Ditech Corporation — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple drugs of abuse IVD, kit, rapid ICT, clinical.

Cleared under the same submission

K050594 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nano-Ditech Corporation

Sources (1)

  • FDA UDI ec51e83c-b34f-43a8-8391-0ebaaad79841 37 fields · synced Jun 9, 2026