FDA UDI
In Commercial Distribution
🇺🇸 United States
Procleix WNV/Babesia Quality Control
DI: 00850032683050
·
Model: Babesia Positive Control
·
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Procleix WNV/Babesia Quality Control
- Primary DI
- 00850032683050
- Version / Model
- Babesia Positive Control
- Company Name
- GRIFOLS DIAGNOSTIC SOLUTIONS INC.
- Labeler DUNS
- 056570085
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-15
- Public Version
- 2
- Public Version Date
- 2023-08-15
- Public Version Status
- Update
- Public Device Record Key
- f123b2f2-bd36-494e-8c8d-e65ddb66b6bb
Device Description
Procleix WNV/Babesia Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of RNA from Babesia microti and West Nile Virus (WNV) with the Procleix Babesia Assay and Procleix WNV Assay respectively performed on the Procleix Panther System.
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| QTM | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening. | Microbiology | 866.3920 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64381 | Multiple Babesia species nucleic acid IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple species of the Babesia protozoa (e.g., B. microti, B. duncani, B. divergens and B. venatorum) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850032683050 | GS1 |
Customer Contacts
- Phone
- 1-800-452-6877
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK220746 | 0 |