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Oral Fluid Methamphetamine Calibrator, Intermediate Calibrator
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Oral Fluid Methamphetamine Calibrator, Intermediate Calibrator FDA UDI
- Generic Name
- Methamphetamine-specific IVD, calibrator FDA UDI
- Device Name
- 5 mL/bottle. Concentration: 100 ng/mL of Methamphetamine. FDA UDI
- Model / Reference
- S0054b FDA UDI
- Description
- 5 mL/bottle. Concentration: 100 ng/mL of Methamphetamine. FDA UDI
Identifiers
- Catalog Number
- S0054b FDA UDI
- Primary DI / UDI-DI
- B076S0054B0 FDA UDI
- 510(k) Number
- K131652 FDA UDI
- FDA Product Code
- DLJ FDA UDI
- GMDN Term
- Methamphetamine-specific 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: Methamphetamine-specific IVD, calibrator
Oral Fluid Methamphetamine Calibrator, Intermediate Calibrator by Lin-Zhi International, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Methamphetamine-specific IVD, calibrator.
- Pointe Methamphetamine Calibrator (1000 ng/mL) Intermediate — POINTE SCIENTIFIC, INC. · Class II
- Pointe Methamphetamine Calibrator (500 ng/mL) Cutoff — POINTE SCIENTIFIC, INC. · Class II
- Pointe Methamphetamine Calibrator (250 ng/mL) Low — POINTE SCIENTIFIC, INC. · Class II
- Pointe Methamphetamine Calibrator (2000 ng/mL) High — POINTE SCIENTIFIC, INC. · Class II
- Methamphetamine DAU Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc. · Class II
- Amphetamines 500 DAU Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc. · Class II
- Amphetamines DAU Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc. · Class II
- Oral Fluid Methamphetamine Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc. · Class II
Cleared under the same submission
K131652 also covers:
- LZI Oral Fluid Collectors — Lin-Zhi International, Inc.
- Oral Fluid Methamphetamine Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc.
- Oral Fluid Methamphetamine Calibrator, High Calibrator — Lin-Zhi International, Inc.
- Oral Fluid Methamphetamine Calibrator, Low Calibrator — Lin-Zhi International, Inc.
- Oral Fluid Methamphetamine Control, Level 1 Control — Lin-Zhi International, Inc.
- Oral Fluid Methamphetamine Control, Level 2 Control — Lin-Zhi International, Inc.
- Oral Fluid Methamphetamine Enzyme Immunoassay — Lin-Zhi International, Inc.
- Oral Fluid Methamphetamine Enzyme Immunoassay — Lin-Zhi International, Inc.
- Oral Fluid Negative 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 a1d68eb1-f2ac-4646-99de-4e4ef63d0e26 36 fields · synced Jun 9, 2026