FDA UDI
In Commercial Distribution
🇺🇸 United States
Premier Bio-Cup & Bio-Dip
DI: B313PBCUP04131
·
Model: PBCup-04-13
·
PREMIER BIOTECH, INC
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- Premier Bio-Cup & Bio-Dip
- Primary DI
- B313PBCUP04131
- Version / Model
- PBCup-04-13
- Catalog Number
- PBCup-04-13
- Company Name
- PREMIER BIOTECH, INC
- Labeler DUNS
- 010118759
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2018-01-23
- Public Version
- 7
- Public Version Date
- 2025-08-11
- Public Version Status
- Update
- Public Device Record Key
- 0fb2ed64-7587-4212-8ecb-8326827b4710
- Distribution End Date
- 2080-01-01
Device Description
AMP500/COC150/OPI300/OXY100
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- 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 |
|---|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | 862.3650 | 2 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | 862.3250 | 2 |
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | 862.3100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46994 | Multiple drugs of abuse IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B313PBCUP04131 | HIBCC | ||||
| Unit of Use | B313PBCUP04130 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius