FDA UDI
In Commercial Distribution
🇺🇸 United States
INFINITI® Factor II BioFilmChip® Microarray Magazine
DI: 00850009370044
·
Model: 01-1020-01
·
AUTOGENOMICS, INC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INFINITI® Factor II BioFilmChip® Microarray Magazine
- Primary DI
- 00850009370044
- Version / Model
- 01-1020-01
- Catalog Number
- 01-1020-01
- 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
- ea6b0e03-c3db-4766-a5f3-ea3f4daaa65d
Device Description
Genotyping system for the detection of Factor II (Prothrombin) G20210A mutations.
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 |
|---|---|---|---|---|
| NPR | TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR | Hematology | 864.7280 | 2 |
| NSU | Instrumentation for clinical multiplex test systems | Clinical Chemistry | 862.2570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58952 | Coagulation factor II (prothrombin) mutation IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict the coagulation factor II (prothrombin) G20210A mutation associated with venous thrombosis, using a nucleic acid technique (NAT). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850009370044 | GS1 |
Customer Contacts
- Phone
- +1(760)477-2248
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K060564 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 8 Degrees Celsius