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Statcup® Ii

FDA UDI

Class U (US FDA UDI)

by Micro Distributing, L.c

Identity

Trade Name
STATCUP® II FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
STAT II DOA 5 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/COC/MAMP/OPI/PCP FDA UDI
Model / Reference
STATⅡ-0257 FDA UDI
Description
STAT II DOA 5 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/COC/MAMP/OPI/PCP FDA UDI

Identifiers

Catalog Number
STATⅡ-0257 FDA UDI
Primary DI / UDI-DI
00816036021762 FDA UDI
FDA Product Code
LCM FDA UDI
DJG FDA UDI
DJC FDA UDI
DIO FDA UDI
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
U FDA UDI
Regulation Number
862.3650 FDA UDI
862.3610 FDA UDI
862.3250 FDA UDI
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

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

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

Statcup® Ii by Micro Distributing, L.c — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Micro Distributing, L.c

Sources (1)

  • FDA UDI 082bd1b3-86f3-4268-a474-33ba7dc01f43 36 fields · synced Jun 8, 2026