FDA UDI
In Commercial Distribution
🇺🇸 United States
PCRopsis
DI: B550783360010
·
Model: Reagent RVD with RVD Enhancer
·
ENTOPSIS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PCRopsis
- Primary DI
- B550783360010
- Version / Model
- Reagent RVD with RVD Enhancer
- Catalog Number
- 78336001
- Company Name
- ENTOPSIS, LLC
- Labeler DUNS
- 078294784
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-11
- Public Version
- 1
- Public Version Date
- 2024-04-19
- Public Version Status
- New
- Public Device Record Key
- 10fabd97-81df-4e4e-99a2-bcc3932f056c
Device Description
PCRopsis™ Reagent RVD with RVD Enhancer (1 mL) mediates extraction-free RT-qPCR of various specimens transported in compatible transport medium.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJH | Clinical Sample Concentrator | Clinical Chemistry | 862.2310 | 1 |
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 | B550783360010 | HIBCC |