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Multi-Analyte DAU Calibrator Set A, High Calibrator
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Multi-Analyte DAU Calibrator Set A, High Calibrator FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, calibrator FDA UDI
- Device Name
- 15mL/bottle. Concentration of Multi-Analyte: 1000 ng/mL benzoylecgonine, 1000 ng/mL d-methamphetamine, 1000 ng/mL methadone, and 40 ng/mL 6-acetylmorphine. FDA UDI
- Model / Reference
- 0815 FDA UDI
- Description
- 15mL/bottle. Concentration of Multi-Analyte: 1000 ng/mL benzoylecgonine, 1000 ng/mL d-methamphetamine, 1000 ng/mL methadone, and 40 ng/mL 6-acetylmorphine. FDA UDI
Identifiers
- Catalog Number
- 0815 FDA UDI
- Primary DI / UDI-DI
- B07608150 FDA UDI
- 510(k) Number
- K133710 FDA UDI
- FDA Product Code
- DKB FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3200 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, calibrator
Multi-Analyte DAU Calibrator Set A, High Calibrator by Lin-Zhi International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple drugs of abuse IVD, calibrator.
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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, 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.
- Multi-Analyte DAU Calibrator Set B, High 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 II | Pending data |
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Manufacturer
- Manufacturer
- Lin-Zhi International, Inc.
Sources (1)
- FDA UDI 482744db-0779-4b61-8b11-0660e34f4ba5 36 fields · synced Jun 9, 2026