Identity
- Trade Name
- Amphetamines 500 DAU Control, Level 1 Control FDA UDI
- Generic Name
- Methamphetamine-specific IVD, control FDA UDI
- Device Name
- 5mL/bottle. Concentration: 375 ng/mL of Methamphetamine. FDA UDI
- Model / Reference
- 0107 FDA UDI
- Description
- 5mL/bottle. Concentration: 375 ng/mL of Methamphetamine. FDA UDI
Identifiers
- Catalog Number
- 0107 FDA UDI
- Primary DI / UDI-DI
- B07601070 FDA UDI
- 510(k) Number
- K102210 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
Amphetamines 500 DAU Control, Level 1 Control by Lin-Zhi International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Methamphetamine-specific IVD, control.
- Pointe Methamphetamine Control (375 ng/mL) Level 1 — POINTE SCIENTIFIC, INC. · Class I
- Pointe Methamphetamine Control (625 ng/mL) Level 2 — POINTE SCIENTIFIC, INC. · Class I
- Methamphetamine DAU Control, Level 1 Control — Lin-Zhi International, Inc. · Class I
- Amphetamines 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
Cleared under the same submission
K102210 also covers:
- Amphetamines 500 DAU Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc.
- Amphetamines 500 DAU Calibrator, High Calibrator — Lin-Zhi International, Inc.
- Amphetamines 500 DAU Calibrator, Intermediate Calibrator — Lin-Zhi International, Inc.
- Amphetamines 500 DAU Calibrator, Low Calibrator — Lin-Zhi International, Inc.
- Amphetamines 500 DAU Control, Level 2 Control — Lin-Zhi International, Inc.
- Amphetamines 500 Enzyme Immunoassay — Lin-Zhi International, Inc.
- Amphetamines 500 Enzyme Immunoassay — Lin-Zhi International, Inc.
- Pointe Amphetamines 500 Calibrator (MAMP 1000 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Amphetamines 500 Calibrator (MAMP 2000 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Amphetamines 500 Calibrator (MAMP 250 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Amphetamines 500 Calibrator (MAMP 500 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Amphetamines 500 Level 1 Control (MAMP 375 ng/mL) — 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
- Lin-Zhi International, Inc.
Sources (1)
- FDA UDI 9cb7366a-93c4-408e-ae91-61551a6f6d95 36 fields · synced Jun 9, 2026