Identity
- Trade Name
- Pointe Methamphetamine Control (375 ng/mL) Level 1 FDA UDI
- Generic Name
- Methamphetamine-specific IVD, control FDA UDI
- Device Name
- Pointe Methamphetamine Control (375 ng/mL) Level 1 1 x 5 mL The Pointe Methamphetamine Controls are for use as assayed quality control materials to monitor the precision of the Pointe Methamphetamine Reagent Set (Ref# 60-MP0700-100/60-MP0700-1L) on number of automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 60-MP0714-5 FDA UDI
- Description
- Pointe Methamphetamine Control (375 ng/mL) Level 1 1 x 5 mL The Pointe Methamphetamine Controls are for use as assayed quality control materials to monitor the precision of the Pointe Methamphetamine Reagent Set (Ref# 60-MP0700-100/60-MP0700-1L) on number of automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 60-MP0714-5 FDA UDI
- Primary DI / UDI-DI
- 00811727018366 FDA UDI
- 510(k) Number
- K113661 FDA UDI
- FDA Product Code
- LAS FDA UDI
- GMDN Term
- Methamphetamine-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: Methamphetamine-specific IVD, control
Pointe Methamphetamine 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 Methamphetamine-specific IVD, control.
- Methamphetamine DAU Control, Level 1 Control — Lin-Zhi International, Inc. · Class I
- Amphetamines DAU Control, Level 1 Control — Lin-Zhi International, Inc. · Class I
- Amphetamines 500 DAU Control, Level 1 Control — Lin-Zhi International, Inc. · Class I
- Oral Fluid Methamphetamine Control, Level 2 Control — Lin-Zhi International, Inc. · Class I
- Amphetamines 500 DAU Control, Level 2 Control — Lin-Zhi International, Inc. · Class I
- Amphetamines DAU Control, Level 2 Control — Lin-Zhi International, Inc. · Class I
- Methamphetamine DAU Control, Level 2 Control — Lin-Zhi International, Inc. · Class I
- Oral Fluid Methamphetamine Control, Level 1 Control — Lin-Zhi International, Inc. · Class I
Cleared under the same submission
K113661 also covers:
- Methamphetamine DAU Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc.
- Methamphetamine DAU Calibrator, High Calibrator — Lin-Zhi International, Inc.
- Methamphetamine DAU Calibrator, Intermediate Calibrator — Lin-Zhi International, Inc.
- Methamphetamine DAU Calibrator, Low Calibrator — Lin-Zhi International, Inc.
- Methamphetamine DAU Control, Level 1 Control — Lin-Zhi International, Inc.
- Methamphetamine DAU Control, Level 2 Control — Lin-Zhi International, Inc.
- Methamphetamine Enzyme Immunoassay — Lin-Zhi International, Inc.
- Methamphetamine Enzyme Immunoassay — Lin-Zhi International, Inc.
- Pointe Methamphetamine Calibrator (1000 ng/mL) Intermediate — POINTE SCIENTIFIC, INC.
- Pointe Methamphetamine Calibrator (2000 ng/mL) High — POINTE SCIENTIFIC, INC.
- Pointe Methamphetamine Calibrator (250 ng/mL) Low — POINTE SCIENTIFIC, INC.
- Pointe Methamphetamine Calibrator (500 ng/mL) Cutoff — 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 80c5e349-6251-4b4e-8092-344c82c5ffc4 37 fields · synced Jun 7, 2026