FDA UDI
In Commercial Distribution
🇺🇸 United States
Pointe Benzodiazepine Reagent Set
DI: 00811727017109
·
Model: 60-BZ0260-100
·
POINTE SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pointe Benzodiazepine Reagent Set
- Primary DI
- 00811727017109
- Version / Model
- 60-BZ0260-100
- Catalog Number
- 60-BZ0260-100
- Company Name
- POINTE SCIENTIFIC, INC.
- Labeler DUNS
- 045623154
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-25
- Public Version
- 1
- Public Version Date
- 2020-10-05
- Public Version Status
- New
- Public Device Record Key
- 2441a612-99fb-4a76-80a0-d760dc0e73fd
Device Description
Pointe Benzodiazepine Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Benzodiazepine Reagent Set is intended for the qualitative and semi-quantitative determination of benzodiazepines in human urine at a cutoff value of 200 ng/mL or 300 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
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 |
|---|---|---|---|---|
| JXM | Enzyme Immunoassay, Benzodiazepine | Clinical Toxicology | 862.3170 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55525 | Benzodiazepine group 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 one or multiple benzodiazepines 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 | 00811727017109 | GS1 |
Customer Contacts
- Phone
- 800-445-9853
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K032365 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius