FDA UDI
In Commercial Distribution
🇺🇸 United States
DM EXL LOCI BRAHMS PCT
DI: 00630414238692
·
Model: 11354447
·
Siemens Healthcare Diagnostics Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- DM EXL LOCI BRAHMS PCT
- Primary DI
- 00630414238692
- Version / Model
- 11354447
- Catalog Number
- RF648
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 005088112
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2022-11-15
- Public Version
- 1
- Public Version Date
- 2022-11-23
- Public Version Status
- New
- Public Device Record Key
- 0e44fd31-1036-4ee8-8989-d61c84331653
Device Description
Procalcitonin (PCT) DM EXL LOCI BRAHMS - RGT
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|
| 54316 | Procalcitonin (PCT) IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00630414298214 | GS1 | ||||
| Primary | 00630414238692 | GS1 |
Customer Contacts
- Phone
- +1(800)441-9250
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220262 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius