Identity
- Trade Name
- Opiate 2000 DAU Calibrator, High Calibrator FDA UDI
- Generic Name
- Opiate/opiate metabolite IVD, calibrator FDA UDI
- Device Name
- 5mL/bottle. Concentration: 6000 ng/mL of Morphine. FDA UDI
- Model / Reference
- 0335 FDA UDI
- Description
- 5mL/bottle. Concentration: 6000 ng/mL of Morphine. FDA UDI
Identifiers
- Catalog Number
- 0335 FDA UDI
- Primary DI / UDI-DI
- B07603350 FDA UDI
- 510(k) Number
- K120761 FDA UDI
- FDA Product Code
- DLJ FDA UDI
- GMDN Term
- Opiate/opiate metabolite 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: Opiate/opiate metabolite IVD, calibrator
Opiate 2000 DAU Calibrator, High Calibrator by Lin-Zhi International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K120761 also covers:
- Opiate 2000 DAU Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc.
- Opiate 2000 DAU Calibrator, Intermediate Calibrator — Lin-Zhi International, Inc.
- Opiate 2000 DAU Calibrator, Low Calibrator — Lin-Zhi International, Inc.
- Opiate 2000 DAU Control, Level 1 Control — Lin-Zhi International, Inc.
- Opiate 2000 DAU Control, Level 2 Control — Lin-Zhi International, Inc.
- Opiate 2000 Enzyme Immunoassay — Lin-Zhi International, Inc.
- Opiate 2000 Enzyme Immunoassay — Lin-Zhi International, Inc.
- Pointe Opiates 2000 Calibrator (Morphine 1000 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Opiates 2000 Calibrator (Morphine 2000 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Opiates 2000 Calibrator (Morphine 4000 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Opiates 2000 Calibrator (Morphine 6000 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Opiates 2000 Level 1 Control (Morphine 1500 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 II | Pending data |
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Manufacturer
- Manufacturer
- Lin-Zhi International, Inc.
Sources (1)
- FDA UDI 14d4b132-d389-4a2f-9b30-66b3748e4924 36 fields · synced Jun 9, 2026