FDA UDI
In Commercial Distribution
🇺🇸 United States
LZI Oral Fluid Collectors
DI: B076S0000B1
·
Model: S0000b
·
LIN-ZHI INTERNATIONAL, INC.
Product Codes
5
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- LZI Oral Fluid Collectors
- Primary DI
- B076S0000B1
- Version / Model
- S0000b
- Catalog Number
- S0000b
- Company Name
- LIN-ZHI INTERNATIONAL, INC.
- Labeler DUNS
- 840839190
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-07-07
- Public Version
- 5
- Public Version Date
- 2021-07-22
- Public Version Status
- Update
- Public Device Record Key
- ff6646b8-cff0-4c53-a409-56526607fe64
Device Description
High-density polypropylene (HDPE) 50 mL centrifuge tubes.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LAS | Drug Specific Control Materials | Clinical Toxicology | 862.3280 | 1 |
| DLJ | Calibrators, Drug Specific | Clinical Toxicology | 862.3200 | 2 |
| LAF | Gas Chromatography, Methamphetamine | Clinical Toxicology | 862.3610 | 2 |
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | 862.3100 | 2 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | 862.3650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38868 | Drug-testing specimen collection kit IVD | A covered receptacle and other associated materials/tools, available for use in the home and clinical settings, intended to be used for the collection, and preservation and/or transport, of a clinical specimen that may include hair, urine, sweat, or saliva suitable for drug testing and/or other in vitro diagnostic investigation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B076S0000B1 | HIBCC | ||||
| Unit of Use | B076S0000B0 | HIBCC |