FDA UDI
In Commercial Distribution
🇺🇸 United States
Procleix Zika Virus Assay
DI: 00859882007481
·
Model: 1K Calibrators
·
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Procleix Zika Virus Assay
- Primary DI
- 00859882007481
- Version / Model
- 1K Calibrators
- Company Name
- GRIFOLS DIAGNOSTIC SOLUTIONS INC.
- Labeler DUNS
- 056570085
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-27
- Public Version
- 1
- Public Version Date
- 2019-03-11
- Public Version Status
- New
- Public Device Record Key
- 06d8f6e5-a11c-4fab-b911-0b67cd54fa99
Device Description
The Procleix Zika Virus Assay is a qualitative in vitro nucleic acid amplification test for the detection of Zika virus (ZIKV) RNA in plasma and serum specimens from human donors.
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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49103 | Zika virus nucleic acid IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from Zika virus in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859882007481 | GS1 |