Identity
- Trade Name
- MDMA CAL FDA UDI
- Generic Name
- Amphetamine/methamphetamine group IVD, calibrator FDA UDI
- Device Name
- The Randox Ecstasy Calibrator Set is intended for use in the calibration of the Ecstasy assay. FDA UDI
- Model / Reference
- DA2701 FDA UDI
- Description
- The Randox Ecstasy Calibrator Set is intended for use in the calibration of the Ecstasy assay. FDA UDI
Identifiers
- Catalog Number
- DA2701 FDA UDI
- Primary DI / UDI-DI
- 05055273207859 FDA UDI
- 510(k) Number
- K092275 FDA UDI
- FDA Product Code
- DLJ FDA UDI
- GMDN Term
- Amphetamine/methamphetamine group IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3200 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
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
Category: Amphetamine/methamphetamine group IVD, calibrator
Mdma Cal by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Amphetamine/methamphetamine group IVD, calibrator.
- Syva® Emit® Calibrator B Level 1 (cutoff) — Siemens Healthcare Diagnostics · Class II
- Ecstasy DAU Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc. · Class II
- Pointe Amphetamines 1000 Calibrator (MAMP 2000 ng/mL) — POINTE SCIENTIFIC, INC. · Class II
- Pointe Amphetamines 500 Calibrator (MAMP 250 ng/mL) — POINTE SCIENTIFIC, INC. · Class II
- Pointe Amphetamines 500 Calibrator (MAMP 1000 ng/mL) — POINTE SCIENTIFIC, INC. · Class II
- Ecstasy DAU Calibrator, High Calibrator — Lin-Zhi International, Inc. · Class II
- Pointe Amphetamines 1000 Calibrator (MAMP 1500 ng/mL) — POINTE SCIENTIFIC, INC. · Class II
- Ecstasy DAU Calibrator, Low Calibrator — Lin-Zhi International, Inc. · Class II
Cleared under the same submission
K092275 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 947caf24-f681-4df8-a6bc-939eb9ea354f 37 fields · synced May 30, 2026