FDA UDI
In Commercial Distribution
🇺🇸 United States
Pointe Cannabinoids (THC) Calibrator (200 ng/mL)
DI: 00811727017376
·
Model: 60-TH0158-5
·
POINTE SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pointe Cannabinoids (THC) Calibrator (200 ng/mL)
- Primary DI
- 00811727017376
- Version / Model
- 60-TH0158-5
- Catalog Number
- 60-TH0158-5
- 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
- 2
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- d97050d8-85b9-46c0-8256-bfe7914ed73a
Device Description
Pointe Cannabinoids (THC) Calibrator (200 ng/mL) 1 x 5 mL The Pointe Cannabinoids (THC) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Cannabinoids (THC) Reagent Set (Ref# 60-CA0140-100/60-CA0140-1L) on 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 |
|---|---|---|---|---|
| DLJ | Calibrators, Drug Specific | Clinical Toxicology | 862.3200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55551 | Cannabinoid/cannabinoid metabolite IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811727017376 | GS1 |
Customer Contacts
- Phone
- 800-445-9853
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110239 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius