Identity
- Trade Name
- Multi-Analyte DAU Control Set B, Level 2 Control FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, control FDA UDI
- Device Name
- 15mL/bottle. Concentration of Multi-Analyte: 625 ng/mL MDMA, 2500 ng/mL morphine, 250 ng/mL oxazepam, and 250 ng/mL secobarbital. FDA UDI
- Model / Reference
- 0838 FDA UDI
- Description
- 15mL/bottle. Concentration of Multi-Analyte: 625 ng/mL MDMA, 2500 ng/mL morphine, 250 ng/mL oxazepam, and 250 ng/mL secobarbital. FDA UDI
Identifiers
- Catalog Number
- 0838 FDA UDI
- Primary DI / UDI-DI
- B07608380 FDA UDI
- 510(k) Number
- K133710 FDA UDI
- FDA Product Code
- DIF FDA UDI
- GMDN Term
- Multiple drugs of abuse 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: Multiple drugs of abuse IVD, control
Multi-Analyte DAU Control Set B, Level 2 Control by Lin-Zhi International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K133710 also covers:
- Synermed® — INFRARED LABORATORY SYSTEMS LLC
- Synermed® — INFRARED LABORATORY SYSTEMS LLC
- Synermed® — INFRARED LABORATORY SYSTEMS LLC
- Synermed® — INFRARED LABORATORY SYSTEMS LLC
- Synermed® — INFRARED LABORATORY SYSTEMS LLC
- Synermed® — INFRARED LABORATORY SYSTEMS LLC
- Synermed® — INFRARED LABORATORY SYSTEMS LLC
- Multi-Analyte DAU Calibrator Set A, Cutoff Calibrator — Lin-Zhi International, Inc.
- Multi-Analyte DAU Calibrator Set A, High Calibrator — Lin-Zhi International, Inc.
- Multi-Analyte DAU Calibrator Set A, Intermediate Calibrator — Lin-Zhi International, Inc.
- Multi-Analyte DAU Calibrator Set A, Low Calibrator — Lin-Zhi International, Inc.
- Multi-Analyte DAU Calibrator Set B, Cutoff Calibrator — 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
- Lin-Zhi International, Inc.
Sources (1)
- FDA UDI 06b6d198-b3a6-445c-9dee-c3a8e8f90bc5 36 fields · synced Jun 9, 2026