FDA UDI
In Commercial Distribution
🇺🇸 United States
MBT HT Sepsityper CA Module
DI: 04251204328285
·
Model: 1892646
·
Bruker Daltonik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MBT HT Sepsityper CA Module
- Primary DI
- 04251204328285
- Version / Model
- 1892646
- Company Name
- Bruker Daltonik GmbH
- Labeler DUNS
- 318387958
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-28
- Public Version
- 1
- Public Version Date
- 2025-12-08
- Public Version Status
- New
- Public Device Record Key
- fdb35234-0089-4d4d-9101-ba7ab9d909d8
Device Characteristics
- Single Use
- No
- 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
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QBN | Mass spectrometry, MALDI TOF, microorganism identification, cultured isolates | Microbiology | 866.3378 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61487 | Human infectome analysis interpretive software IVD | An in vitro diagnostic interpretive software program intended to be used to aid the identification of infectious microbial species [bacterial, fungal, viral] in a clinical specimen using images from microbial cultures and laboratory biochemical tests (e.g., digital profiles), or by genetic profiling via nucleic acid analysis. Results from in vitro diagnostic tests are input and the presumptive name(s), probability of possible microbial species, and/or information on genetic variants (e.g., subtype, genotype, strain) are returned. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04251204328285 | GS1 |
Customer Contacts
- Phone
- +1(877)442-2231
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251495 | 000 |