FDA UDI
In Commercial Distribution
🇺🇸 United States
Cocaine Metabolite Enzyme Immunoassay
DI: B07600300
·
Model: 0030
·
LIN-ZHI INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Cocaine Metabolite Enzyme Immunoassay
- Primary DI
- B07600300
- Version / Model
- 0030
- Catalog Number
- 0030
- Company Name
- LIN-ZHI INTERNATIONAL, INC.
- Labeler DUNS
- 840839190
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-05
- Public Version
- 4
- Public Version Date
- 2018-08-24
- Public Version Status
- Update
- Public Device Record Key
- 3af84f39-e405-45e4-a9bb-d9504383d621
Device Description
Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | 862.3250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55562 | Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA), | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cocaine and/or cocaine metabolites in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B07600300 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K020763 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius