Identity
- Trade Name
- Opiate DAU Control, Level 2 Control FDA UDI
- Generic Name
- Opiate/opiate metabolite IVD, control FDA UDI
- Device Name
- 5mL/bottle. Concentration: 375 ng/mL of Morphine. FDA UDI
- Model / Reference
- 0028 FDA UDI
- Description
- 5mL/bottle. Concentration: 375 ng/mL of Morphine. FDA UDI
Identifiers
- Catalog Number
- 0028 FDA UDI
- Primary DI / UDI-DI
- B07600280 FDA UDI
- 510(k) Number
- K020769 FDA UDI
- FDA Product Code
- LAS FDA UDI
- GMDN Term
- Opiate/opiate metabolite 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: Opiate/opiate metabolite IVD, control
Opiate DAU Control, Level 2 Control by Lin-Zhi International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Opiate/opiate metabolite IVD, control.
- Synchron — Beckman Coulter, Inc. · Class I
- Immunalysis — Immunalysis Corporation · Class I
- ARK™ Fentanyl Control (WPT) — ARK DIAGNOSTICS INC · Class I
- Pointe Opiates 2000 Level 2 Control (Morphine 2500 ng/mL) — POINTE SCIENTIFIC, INC. · Class I
- Pain Management 100 — UTAK LABORATORIES, INC. · Class I
- OPIATES HYDROLYSIS QC — UTAK LABORATORIES, INC. · Class I
- Pointe Opiates 2000 Level 1 Control (Morphine 1500 ng/mL) — POINTE SCIENTIFIC, INC. · Class I
- BUPRENORPHINE PLUS LEVEL 1 — UTAK LABORATORIES, INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lin-Zhi International, Inc.
Sources (1)
- FDA UDI d017658d-d5f6-463e-8e93-f2e599c97ecc 36 fields · synced Jun 9, 2026