FDA UDI
In Commercial Distribution
🇺🇸 United States
xTAG® CYP2C19 Kit v3
DI: 00840487100172
·
Model: I046B0427
·
Luminex Molecular Diagnostics, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- xTAG® CYP2C19 Kit v3
- Primary DI
- 00840487100172
- Version / Model
- I046B0427
- Catalog Number
- I046B0427
- Company Name
- Luminex Molecular Diagnostics, Inc
- Labeler DUNS
- 255371916
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 1e707d5b-5d67-4ce3-8bc6-b16c152d3823
Device Description
The xTAG® CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP450 2C19 gene, located on chromosome 10q24, from genomic DNA extracted from EDTA or citrate anticoagulated whole blood samples.
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| NTI | Drug metabolizing enzyme genotyping systems | Clinical Toxicology | 862.3360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60519 | Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex | A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose or predict gene polymorphisms within the Cytochrome P450 superfamily (CYP450) that are associated with metabolism of xenobiotics/drugs, including warfarin, analgesics and/or anti-depressants, using a multiplex method. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840487100172 | GS1 |
Customer Contacts
- Phone
- +1(877)785-2323
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131565 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – -15 Degrees Celsius