FDA UDI
In Commercial Distribution
🇺🇸 United States
INFINITI® Warfarin BioFilmChip® Microarray Magazine
DI: 00850009370167
·
Model: 03-1140-01
·
AUTOGENOMICS, INC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INFINITI® Warfarin BioFilmChip® Microarray Magazine
- Primary DI
- 00850009370167
- Version / Model
- 03-1140-01
- Catalog Number
- 03-1140-01
- Company Name
- AUTOGENOMICS, INC
- Labeler DUNS
- 027914535
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-23
- Public Version
- 1
- Public Version Date
- 2019-10-31
- Public Version Status
- New
- Public Device Record Key
- 15f6467e-57d7-411c-ae32-409c6ffb3d91
Device Description
CYP450 2C9 drug metabolizing enzyme and VKORC1 genotyping 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
- Yes
- 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 |
|---|---|---|---|---|
| ODW | Cytochrome P450 2C9 (Cyp450 2c9) drug metabolizing enzyme genotyping system | Clinical Toxicology | 862.3360 | 2 |
| ODV | Vitamin k epoxide reductase complex subunit one (vkorc1) genotyping system | Hematology | 864.7750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63207 | Anticoagulant-resistance multiple genetic risk factor IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to predict or monitor the genetic predisposition of a patient exhibiting resistance to anticoagulation agents based on multiple genetic markers which may include the Cytochrome P450 superfamily (CYP450) and Vitamin K epoxide reductase complex subunit-1 (VKORC1) gene polymorphisms, using a nucleic acid technique (NAT). It is used to aid therapy management of patients with thromboembolic disease typically treated with coumarin derivatives (e.g., warfarin). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850009370167 | GS1 |
Customer Contacts
- Phone
- +1(760)477-2248
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K073014 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 8 Degrees Celsius