FDA UDI
In Commercial Distribution
🇺🇸 United States
PAXgene® Blood RNA Kit
DI: 04053727000149
·
Model: Version 2
·
PreAnalytiX GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PAXgene® Blood RNA Kit
- Primary DI
- 04053727000149
- Version / Model
- Version 2
- Catalog Number
- 762164
- Company Name
- PreAnalytiX GmbH
- Labeler DUNS
- 480915029
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-26
- Public Version
- 1
- Public Version Date
- 2025-03-06
- Public Version Status
- New
- Public Device Record Key
- 5613af38-5f7b-4250-8732-42d0e77c68a7
Device Description
The PAXgene® Blood RNA Kit isolates and purifies RNA from blood collected in a PAXgene® Blood RNA Tube.
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 |
|---|---|---|---|---|
| NTW | System, blood collection, rna stabilization, rna purification, rt-pcr molecular diagnostic test | Immunology | 866.4070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52521 | Nucleic acid extraction/isolation kit IVD | A collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04053727000149 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082150 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius