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Oral Fluid 6-Acetylmorphine Control, Level 2 Control
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Oral Fluid 6-Acetylmorphine Control, Level 2 Control FDA UDI
- Generic Name
- 6-Acetyl morphine IVD, control FDA UDI
- Device Name
- 5 mL/bottle. Concentration: 6 ng/mL of 6-Acetylmorphine. FDA UDI
- Model / Reference
- S0297 FDA UDI
- Description
- 5 mL/bottle. Concentration: 6 ng/mL of 6-Acetylmorphine. FDA UDI
Identifiers
- Catalog Number
- S0297 FDA UDI
- Primary DI / UDI-DI
- B076S02970 FDA UDI
- 510(k) Number
- K141205 FDA UDI
- FDA Product Code
- LAS FDA UDI
- GMDN Term
- 6-Acetyl morphine 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: 6-Acetyl morphine IVD, control
Oral Fluid 6-Acetylmorphine 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 6-Acetyl morphine IVD, control.
- Immunalysis — Immunalysis Corporation · Class I
- Immunalysis — Immunalysis Corporation · Class I
- Pointe 6-Acetylmorphine Control (12.5 ng/mL) Level 2 — POINTE SCIENTIFIC, INC. · Class I
- Immunalysis — Immunalysis Corporation · Class I
- Pointe 6-Acetylmorphine Control (7.5 ng/mL) Level 1 — POINTE SCIENTIFIC, INC. · Class I
- 6-Acetylmorphine DAU Control, Level 2 Control — Lin-Zhi International, Inc. · Class I
- 6-Acetylmorphine DAU Control, Level 1 Control — Lin-Zhi International, Inc. · Class I
- Oral Fluid 6-Acetylmorphine Calibrator/Control, Low Calibrator/Level 1 Control — Lin-Zhi International, Inc. · Class I
Cleared under the same submission
K141205 also covers:
- LZI Oral Fluid Collectors — Lin-Zhi International, Inc.
- Oral Fluid 6-Acetylmorphine Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc.
- Oral Fluid 6-Acetylmorphine Calibrator, High Calibrator — Lin-Zhi International, Inc.
- Oral Fluid 6-Acetylmorphine Calibrator, Intermediate Calibrator — Lin-Zhi International, Inc.
- Oral Fluid 6-Acetylmorphine Calibrator, Negative Calibrator — Lin-Zhi International, Inc.
- Oral Fluid 6-Acetylmorphine Calibrator/Control, Low Calibrator/Level 1 Control — Lin-Zhi International, Inc.
- Oral Fluid 6-Acetylmorphine Enzyme Immunoassay — Lin-Zhi International, Inc.
- Oral Fluid 6-Acetylmorphine Enzyme Immunoassay — 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 70ab0031-8faa-4846-b5a0-7e6a337b72b5 36 fields · synced Jun 9, 2026