Identity
- Trade Name
- LZI Oral Fluid Collectors FDA UDI
- Generic Name
- Drug-testing specimen collection kit IVD FDA UDI
- Device Name
- High-density polypropylene (HDPE) 50 mL centrifuge tubes. FDA UDI
- Model / Reference
- S0000b FDA UDI
- Description
- High-density polypropylene (HDPE) 50 mL centrifuge tubes. FDA UDI
Identifiers
- Catalog Number
- S0000b FDA UDI
- Primary DI / UDI-DI
- B076S0000B1 FDA UDI
- FDA Product Code
- LAS FDA UDIDLJ FDA UDILAF FDA UDIDKZ FDA UDIDJG FDA UDI
- GMDN Term
- Drug-testing specimen collection kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3280 FDA UDI862.3200 FDA UDI862.3610 FDA UDI862.3100 FDA UDI862.3650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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: Drug-testing specimen collection kit IVD
LZI Oral Fluid Collectors 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
K131652 also covers:
- Oral Fluid Methamphetamine Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc.
- Oral Fluid Methamphetamine Calibrator, High Calibrator — Lin-Zhi International, Inc.
- Oral Fluid Methamphetamine Calibrator, Intermediate 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.
K131653 also covers:
- Oral Fluid Amphetamine Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc.
- Oral Fluid Amphetamine Calibrator, High Calibrator — Lin-Zhi International, Inc.
- Oral Fluid Amphetamine Calibrator, Intermediate Calibrator — Lin-Zhi International, Inc.
- Oral Fluid Amphetamine Calibrator, Low Calibrator — Lin-Zhi International, Inc.
- Oral Fluid Amphetamine Control, Level 1 Control — Lin-Zhi International, Inc.
- Oral Fluid Amphetamine Control, Level 2 Control — Lin-Zhi International, Inc.
- Oral Fluid Amphetamine Enzyme Immunoassay — Lin-Zhi International, Inc.
- Oral Fluid Amphetamine Enzyme Immunoassay — Lin-Zhi International, Inc.
- Oral Fluid Negative Calibrator — Lin-Zhi International, Inc.
K141205 also covers:
- 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 Control, Level 2 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.
K141320 also covers:
- Oral Fluid Cannabinoid Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc.
- Oral Fluid Cannabinoid Calibrator, High Calibrator — Lin-Zhi International, Inc.
- Oral Fluid Cannabinoid Calibrator, Intermediate Calibrator — Lin-Zhi International, Inc.
- Oral Fluid Cannabinoid Calibrator, Low Calibrator — Lin-Zhi International, Inc.
- Oral Fluid Cannabinoid Calibrator, Negative Calibrator — Lin-Zhi International, Inc.
- Oral Fluid Cannabinoid Control, Level 1 Control — Lin-Zhi International, Inc.
- Oral Fluid Cannabinoid Control, Level 2 Control — Lin-Zhi International, Inc.
- Oral Fluid Cannabinoid Enzyme Immunoassay — Lin-Zhi International, Inc.
- Oral Fluid Cannabinoid 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 ff6646b8-cff0-4c53-a409-56526607fe64 35 fields · synced Jun 9, 2026