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Statdip®

FDA UDI

Class II (US FDA UDI)

by Micro Distributing, L.c

Identity

Trade Name
STATDIP® FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
Single STATDIP CLIA WAIVED Dip Card, Propoxyphene (PPX), 25Pcs/Box FDA UDI
Model / Reference
DPP-114-0 FDA UDI
Description
Single STATDIP CLIA WAIVED Dip Card, Propoxyphene (PPX), 25Pcs/Box FDA UDI

Identifiers

Catalog Number
DPP-114-0 FDA UDI
Primary DI / UDI-DI
00816036025623 FDA UDI
510(k) Number
K152495 FDA UDI
FDA Product Code
JXN FDA UDI
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3700 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

Statdip® by Micro Distributing, L.c — Class II — 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

K152495 also covers:

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 1bbf8f18-f90b-4a15-a4e0-f527ac32c958 37 fields · synced May 30, 2026