FDA UDI
In Commercial Distribution
🇺🇸 United States
HPV E6, E7 mRNA Probe
DI: B766C311000
·
Model: C31100
·
INCELLDX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HPV E6, E7 mRNA Probe
- Primary DI
- B766C311000
- Version / Model
- C31100
- Catalog Number
- C31100
- Company Name
- INCELLDX, INC.
- Labeler DUNS
- 833074623
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-19
- Public Version
- 2
- Public Version Date
- 2019-11-21
- Public Version Status
- Update
- Public Device Record Key
- 25ff6a99-dbc6-4f52-97bd-71ae15a87c8f
Device Description
HPV E6, E7 mRNA Probe is specific for Human Papillomavirus types 16 and 18 E6,E7 mRNA. HPV E6,E7 genes are transcribed as a single transcript using a common promoter and early polyadenylation site. HPV E6, E7 mRNA Probe is comprised of a cocktail of 85% pure full-length dual fluorescein-labelled molecules as verified by Reverse Phase HPLC.
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
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| MVU | Reagents, Specific, Analyte | Pathology | 864.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61199 | Nucleic acid hybridization detection IVD, probe | A defined piece(s) of nucleic acid, typically tagged with a fluorescent marker, intended to be used for the detection of a specific target nucleotide sequence at a single-gene locus or whole/partial chromosome level in a clinical specimen, in order to identify chromosomal abnormalities (e.g., aneuploidy, deletion, translocation, duplication, inversion, gene insertion). It is typically used in nucleic acid hybridization detection techniques [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH)]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B766C311000 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 315 | Microliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius