FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Procalcitonin LiquiColor
DI: 00657498001950
·
Model: 2300-060
·
STANBIO LABORATORY, L.P.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Procalcitonin LiquiColor
- Primary DI
- 00657498001950
- Version / Model
- 2300-060
- Catalog Number
- 2300-060
- 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
- 4
- Public Version Date
- 2026-02-09
- Public Version Status
- Update
- Public Device Record Key
- 86e8dce9-77e4-4f3f-a61a-53af2ecdeafa
- Distribution End Date
- 2022-08-30
Device Description
Stanbio Procalcitonin (PCT) LiquiColor® is intended for the quantitative determination of PCT in human serum samples, EDTA or lithium heparin plasma samples by latex enhanced immunoturbidimetric method. This test is used in conjunction with other laboratory tests and clinical examinations to aid in the risk assessment of ill patients on their initial hospital admission for the potential development of sepsis and/ or septic shock.
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 |
|---|---|---|---|---|
| 54316 | Procalcitonin (PCT) IVD, reagent | A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection 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 | 00657498001950 | GS1 |
Customer Contacts
- Phone
- 18005315535
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius