FDA UDI
In Commercial Distribution
🇺🇸 United States
VIDAS® B·R·A·H·M·S PCT ™
DI: 03573026223601
·
Model: 30450-01
·
BIOMERIEUX SA
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VIDAS® B·R·A·H·M·S PCT ™
- Primary DI
- 03573026223601
- Version / Model
- 30450-01
- Company Name
- BIOMERIEUX SA
- Labeler DUNS
- 276816717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- eae7fa54-29ea-4d48-96b0-146e0a7c8b4d
Device Description
VIDAS ® B·R·A·H·M·S PCT™ (PCT) is an automated test for use on the VIDAS ® instruments for the determination of procalcitonin in human serum or plasma.
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 |
|---|---|---|---|---|
| NTM | Antigen, Inflammatory Response Marker, Sepsis | Microbiology | 866.3210 | 2 |
| PMT | Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens | Microbiology | 866.3215 | 2 |
| PRI | Procalcitonin Assay | Microbiology | 866.3215 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61534 | Procalcitonin (PCT) IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the quantitative measurement of procalcitonin (PCT) in a clinical specimen, using an enzyme immunoassay (EIA) method. Procalcitonin is typically used as a marker of bacterial sepsis or severe bacterial infection. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03573026223601 | GS1 |
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius