FDA UDI
In Commercial Distribution
🇺🇸 United States
Procleix Syscheck
DI: 00859882007405
·
Model: Instrument Verification Solution
·
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 Syscheck
- Primary DI
- 00859882007405
- Version / Model
- Instrument Verification Solution
- Company Name
- GRIFOLS DIAGNOSTIC SOLUTIONS INC.
- Labeler DUNS
- 056570085
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-03
- Public Version
- 1
- Public Version Date
- 2018-09-03
- Public Version Status
- New
- Public Device Record Key
- f6360d07-4df8-403c-962d-4f5f5c5a2177
Device Description
A collection of reagents and other associated materials intended to be used to generate a chemiluminescent signal when performing an assay using a nucleic acid technique (NAT) on a clinical specimen. It may also include reference material to optimize and verify performance of the luminometer instrument.
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 |
|---|---|---|---|---|
| 61193 | Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD | A collection of reagents and other associated materials intended to be used to generate a chemiluminescent signal when performing an assay using a nucleic acid technique (NAT) on a clinical specimen. The kit is typically used in conjunction with luminescent-labelled nucleic acid oligonucleotide probes of known sequences and may also include reference material to optimise and verify performance of the luminometer instrument. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859882007405 | GS1 |