Identity
- Trade Name
- Ecstasy DAU Calibrator, Cutoff Calibrator FDA UDI
- Generic Name
- Amphetamine/methamphetamine group IVD, calibrator FDA UDI
- Device Name
- 5mL/bottle. Concentration: 500 ng/mL of MDMA. FDA UDI
- Model / Reference
- 0163 FDA UDI
- Description
- 5mL/bottle. Concentration: 500 ng/mL of MDMA. FDA UDI
Identifiers
- Catalog Number
- 0163 FDA UDI
- Primary DI / UDI-DI
- B07601630 FDA UDI
- 510(k) Number
- K033094 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
No
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
Ecstasy DAU Calibrator, Cutoff Calibrator by Lin-Zhi International, Inc. — 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
- MDMA CAL — Randox Laboratories, Ltd. · 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
- Pointe Amphetamines 1000 Calibrator (MAMP 1500 ng/mL) — POINTE SCIENTIFIC, INC. · Class II
- Immunalysis — Immunalysis Corporation · Class II
- Syva® Emit® Calibrator B Level 2 (high) — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K033094 also covers:
- Ecstasy DAU Calibrator, High Calibrator — Lin-Zhi International, Inc.
- Ecstasy DAU Calibrator, Intermediate Calibrator — Lin-Zhi International, Inc.
- Ecstasy DAU Calibrator, Low Calibrator — Lin-Zhi International, Inc.
- Ecstasy DAU Control, Level 1 Control — Lin-Zhi International, Inc.
- Ecstasy DAU Control, Level 2 Control — Lin-Zhi International, Inc.
- Ecstasy Enzyme Immunoassay — Lin-Zhi International, Inc.
- Ecstasy Enzyme Immunoassay — Lin-Zhi International, Inc.
- Pointe Ecstasy (MDMA) Calibrator (100 ng/mL) Low — POINTE SCIENTIFIC, INC.
- Pointe Ecstasy (MDMA) Calibrator (1000 ng/mL) High — POINTE SCIENTIFIC, INC.
- Pointe Ecstasy (MDMA) Calibrator (500 ng/mL) Cutoff — POINTE SCIENTIFIC, INC.
- Pointe Ecstasy (MDMA) Calibrator (750 ng/mL) Intermediate — POINTE SCIENTIFIC, INC.
- Pointe Ecstasy (MDMA) Control (375 ng/mL) Level 1 — POINTE SCIENTIFIC, 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
- Lin-Zhi International, Inc.
Sources (1)
- FDA UDI cd7940be-55c9-4acb-8506-c670550683e8 36 fields · synced Jun 9, 2026