Identity
- Trade Name
- Fastect II Drug Screen Dipstick Test FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- THC50/COC300/OPI300 multiple drugs dipstick test FDA UDI
- Model / Reference
- TF13 FDA UDI
- Description
- THC50/COC300/OPI300 multiple drugs dipstick test FDA UDI
Identifiers
- Catalog Number
- TF13 FDA UDI
- Primary DI / UDI-DI
- 00816565021240 FDA UDI
- 510(k) Number
- K022355 FDA UDI
- FDA Product Code
- DJG FDA UDIDIO FDA UDILDJ FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3650 FDA UDI862.3250 FDA UDI862.3870 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
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
No
FDA UDI
Fastect II Drug Screen Dipstick Test by Ameditech Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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- Alere iScreen Dx — Instant Technologies, Inc.
- Alere iScreen Dx — Instant Technologies, Inc.
- Alere iScreen Dx — Instant Technologies, Inc.
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 |
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Manufacturer
- Manufacturer
- Ameditech Inc.
Sources (1)
- FDA UDI aabff109-2e29-4ba6-8e30-d68286274aa9 38 fields · synced Jun 8, 2026