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Pointe Amphetamines 1000 Level 1 Control (MAMP 750 ng/mL)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Pointe Amphetamines 1000 Level 1 Control (MAMP 750 ng/mL) FDA UDI
- Generic Name
- Amphetamine/methamphetamine group IVD, control FDA UDI
- Device Name
- Pointe Amphetamines 1000 Level 1 Control (MAMP 750 ng/mL) 1 x 5 mL The Pointe Amphetamines 1000 Controls are for use as assayed quality control materials to monitor the precision of the Pointe Amphetamines 1000 Reagent Set (Ref# 60-AM0080-100/60-AM0080-1L) on a number of automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 60-AM0094-5 FDA UDI
- Description
- Pointe Amphetamines 1000 Level 1 Control (MAMP 750 ng/mL) 1 x 5 mL The Pointe Amphetamines 1000 Controls are for use as assayed quality control materials to monitor the precision of the Pointe Amphetamines 1000 Reagent Set (Ref# 60-AM0080-100/60-AM0080-1L) on a number of automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 60-AM0094-5 FDA UDI
- Primary DI / UDI-DI
- 00811727016676 FDA UDI
- 510(k) Number
- K020769 FDA UDI
- FDA Product Code
- LAS FDA UDI
- GMDN Term
- Amphetamine/methamphetamine group 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/methamphetamine group IVD, control
Pointe Amphetamines 1000 Level 1 Control (MAMP 750 ng/mL) by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K020769 also covers:
- Amphetamines DAU Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc.
- Amphetamines DAU Calibrator, High Calibrator — Lin-Zhi International, Inc.
- Amphetamines DAU Calibrator, Intermediate Calibrator — Lin-Zhi International, Inc.
- Amphetamines DAU Calibrator, Low Calibrator — Lin-Zhi International, Inc.
- Amphetamines DAU Control, Level 1 Control — Lin-Zhi International, Inc.
- Amphetamines DAU Control, Level 2 Control — Lin-Zhi International, Inc.
- Cocaine Metabolite DAU Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc.
- Cocaine Metabolite DAU Calibrator, High Calibrator — Lin-Zhi International, Inc.
- Cocaine Metabolite DAU Calibrator, Intermediate Calibrator — Lin-Zhi International, Inc.
- Cocaine Metabolite DAU Calibrator, Low Calibrator — Lin-Zhi International, Inc.
- Cocaine Metabolite DAU Control, Level 1 Control — Lin-Zhi International, Inc.
- Cocaine Metabolite DAU Control, Level 2 Control — Lin-Zhi International, 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 73b93eee-312f-481a-9567-5ef93b8f52f7 37 fields · synced Jun 8, 2026