Identity
- Trade Name
- Pointe Ecstasy (MDMA) Control (375 ng/mL) Level 1 FDA UDI
- Generic Name
- Amphetamine-specific IVD, control FDA UDI
- Device Name
- Pointe Ecstasy (MDMA) Control (375 ng/mL) Level 1 1 x 5 mL The Pointe Ecstasy (MDMA) Controls are for use as assayed quality control materials to monitor the precision of the Pointe Ecstasy (MDMA) Reagent Set (Ref# 60-EC0320-100/60-EC0320-1L) on a number of automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 60-EC0334-5 FDA UDI
- Description
- Pointe Ecstasy (MDMA) Control (375 ng/mL) Level 1 1 x 5 mL The Pointe Ecstasy (MDMA) Controls are for use as assayed quality control materials to monitor the precision of the Pointe Ecstasy (MDMA) Reagent Set (Ref# 60-EC0320-100/60-EC0320-1L) on a number of automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 60-EC0334-5 FDA UDI
- Primary DI / UDI-DI
- 00811727018052 FDA UDI
- 510(k) Number
- K033094 FDA UDI
- FDA Product Code
- LAS FDA UDI
- GMDN Term
- Amphetamine-specific IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3280 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-specific IVD, control
Pointe Ecstasy (MDMA) Control (375 ng/mL) Level 1 by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Amphetamine-specific IVD, control.
- Immunalysis — Immunalysis Corporation · Class I
- Oral Fluid Amphetamine Control, Level 2 Control — Lin-Zhi International, Inc. · Class I
- Immunalysis — Immunalysis Corporation · Class I
- Oral Fluid Amphetamine Control, Level 1 Control — Lin-Zhi International, Inc. · Class I
- Pointe Ecstasy (MDMA) Control (625 ng/mL) Level 2 — POINTE SCIENTIFIC, INC. · Class I
Cleared under the same submission
K033094 also covers:
- Ecstasy DAU Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc.
- 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.
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 I | Pending data |
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Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 78e4fb39-552f-4098-8d73-1075363546a0 37 fields · synced May 30, 2026