Identity
- Trade Name
- QuikStrip MultiDrug X Screening Dip Card FDA UDI
- Generic Name
- Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical FDA UDI
- Device Name
- QuikStrip Multidrug 1 Screening Dip Card Test - MAD 300 ng/ml FDA UDI
- Model / Reference
- 30121 FDA UDI
- Description
- QuikStrip Multidrug 1 Screening Dip Card Test - MAD 300 ng/ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00748349000182 FDA UDI
- 510(k) Number
- K061617 FDA UDI
- FDA Product Code
- DJR FDA UDI
- GMDN Term
- Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3620 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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: Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
QuikStrip MultiDrug X Screening Dip Card by Syntron Bioresearch, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K061617 also covers:
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
- Syntron Bioresearch, Inc.
Sources (1)
- FDA UDI 90c59798-0fb0-4118-b6b5-2b24d163b9ea 34 fields · synced Jun 1, 2026