FDA UDI
In Commercial Distribution
🇺🇸 United States
SeptiCyte RAPID [US IVD]
DI: 10860007612654
·
Model: SB3020U
·
Immunexpress Inc.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SeptiCyte RAPID [US IVD]
- Primary DI
- 10860007612654
- Version / Model
- SB3020U
- Company Name
- Immunexpress Inc.
- Labeler DUNS
- 964789676
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-17
- Public Version
- 1
- Public Version Date
- 2024-03-25
- Public Version Status
- New
- Public Device Record Key
- 52a1da07-7dcd-4005-8497-afd755cfa03a
Device Description
Sepsis Host Response US IVD EDTA PAXgene Variant Dispenser Box
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| PRE | Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers | Microbiology | 866.3215 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52902 | Multiple clinical chemistry enzyme IVD, kit, enzyme fluorescence | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple clinical chemistry enzymes, using an enzyme fluorescence method. Analytes detected may include alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP). | No | Active |
| 60090 | Reverse transcription reagent kit IVD | A collection of reagents and other associated materials intended to be used in the synthesis of complimentary deoxyribonucleic acid (cDNA) by reverse transcription, to facilitate the amplification of target ribonucleic acid (RNA) in a clinical specimen, using a polymerase chain reaction (PCR) technique. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10860007612654 | GS1 |