FDA UDI
In Commercial Distribution
🇺🇸 United States
Procleix Parasite Transport Medium
DI: 00859882007757
·
Model: Lysis Buffer
·
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Procleix Parasite Transport Medium
- Primary DI
- 00859882007757
- Version / Model
- Lysis Buffer
- Company Name
- GRIFOLS DIAGNOSTIC SOLUTIONS INC.
- Labeler DUNS
- 056570085
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-20
- Public Version
- 1
- Public Version Date
- 2019-03-28
- Public Version Status
- New
- Public Device Record Key
- a328df11-2c11-4cb3-a705-9a064f4ba0e3
Device Description
The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the detection of RNA from Babesia species (B. microti, B. duncani, B. divergens, and B. venatorum) in whole blood specimens.
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
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61165 | Blood cell lysis reagent IVD | A substance or reactant intended to be used alone or in combination with other IVDs to disrupt the cell membrane of blood cells [red blood cells (RBCs), white blood cells (WBCs) and/or platelets] to release cytoplasmic contents in preparation for further analysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859882007757 | GS1 |