Identity
- Trade Name
- STATDIP® FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- 12-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BZO/COC/MAMP/MDMA/MOR/MTD/OXY/PCP/TCA/THC, 25Pcs/Box FDA UDI
- Model / Reference
- SDP-2124-0 FDA UDI
- Description
- 12-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BZO/COC/MAMP/MDMA/MOR/MTD/OXY/PCP/TCA/THC, 25Pcs/Box FDA UDI
Identifiers
- Catalog Number
- SDP-2124-0 FDA UDI
- Primary DI / UDI-DI
- 00816036025944 FDA UDI
- 510(k) Number
- K133968 FDA UDI
- FDA Product Code
- LFG FDA UDIDJR FDA UDIDIS FDA UDILAF FDA UDIDIO FDA UDILDJ FDA UDIDJG FDA UDIJXM FDA UDIDKZ FDA UDILCM FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3910 FDA UDI862.3620 FDA UDI862.3150 FDA UDI862.3610 FDA UDI862.3250 FDA UDI862.3870 FDA UDI862.3650 FDA UDI862.3170 FDA UDI862.3100 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
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Cleared under the same submission
K133968 also covers:
- CLIAwaived — CLIAWAIVED,INC.
- Areta Multi-Drug Test Cup (10 tests kit) — EASY HEALTHCARE CORPORATION
- Areta Multi-Drug Test Cup (25 tests kit) — EASY HEALTHCARE CORPORATION
- Areta Multi-Drug Test Cup (50 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home COC Single Drug Screen Test (25 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home Multi-Drug Screen Test (10 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home Multi-Drug Screen Test (10 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home Multi-Drug Screen Test (10 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home Multi-Drug Screen Test (2 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home Multi-Drug Screen Test (25 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home Multi-Drug Screen Test (5 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home Multi-Drug Test Cup (25 tests kit) — EASY HEALTHCARE CORPORATION
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Micro Distributing, L.c
Sources (1)
- FDA UDI 48b7c28b-d2ba-40f8-afd2-3fb93308d2a6 37 fields · synced May 31, 2026