FDA UDI
In Commercial Distribution
🇺🇸 United States
Pointe Phencyclidine (PCP) Level 2 Control (32 ng/mL)
DI: 00811727016522
·
Model: 60-PC0036-5
·
POINTE SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pointe Phencyclidine (PCP) Level 2 Control (32 ng/mL)
- Primary DI
- 00811727016522
- Version / Model
- 60-PC0036-5
- Catalog Number
- 60-PC0036-5
- 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
- 1
- Public Version Date
- 2020-10-05
- Public Version Status
- New
- Public Device Record Key
- 71f1840e-cf04-4cb8-83bd-a4bb6fe309ca
Device Description
Pointe Phencyclidine (PCP) Level 2 Control (32 ng/mL) 1 x 5 mL The Pointe Phencyclidine (PCP) Controls are for use as assayed quality control materials to monitor the precision of the Pointe Phencyclidine (PCP) Reagent Set (Ref# 60-PH0020-100/60-PH0020-1L) 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 |
|---|---|---|---|---|
| LAS | Drug Specific Control Materials | Clinical Toxicology | 862.3280 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55748 | Phencyclidine (PCP) IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of phencyclidine (PCP) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811727016522 | GS1 |
Customer Contacts
- Phone
- 800-445-9853
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K020769 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius