FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Procalcitonin (PCT) Bi-Level Controls
DI: 00657498001974
·
Model: 2320-203
·
STANBIO LABORATORY, L.P.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Procalcitonin (PCT) Bi-Level Controls
- Primary DI
- 00657498001974
- Version / Model
- 2320-203
- Catalog Number
- 2320-203
- Company Name
- STANBIO LABORATORY, L.P.
- Labeler DUNS
- 045361136
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-26
- Public Version
- 3
- Public Version Date
- 2022-08-31
- Public Version Status
- Update
- Public Device Record Key
- 95d04226-f658-4e7a-81a6-7bdbd7b35056
- Distribution End Date
- 2022-08-30
Device Description
The Stanbio Procalcitonin (PCT) Control Set is intended for use as quality control in examining the accuracy and precision of the quantitative Stanbio Procalcitonin (PCT) LiquiColor® Assay.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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 |
|---|---|---|---|---|
| PTF | Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission | Microbiology | 866.3215 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54315 | Procalcitonin (PCT) IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of procalcitonin (PCT) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00657498001974 | GS1 |
Customer Contacts
- Phone
- 18005315535
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius