FDA UDI
In Commercial Distribution
🇺🇸 United States
AvertD™ (96) AMP Mix
DI: 10850009370256
·
Model: 03-7560-01
·
AUTOGENOMICS, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AvertD™ (96) AMP Mix
- Primary DI
- 10850009370256
- Version / Model
- 03-7560-01
- Catalog Number
- 03-7560-01
- Company Name
- AUTOGENOMICS, INC
- Labeler DUNS
- 027914535
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-18
- Public Version
- 1
- Public Version Date
- 2024-11-26
- Public Version Status
- New
- Public Device Record Key
- f2b7cc42-bb4f-43fa-8931-b45a970c6649
Device Description
The Amplification Mix provides the reagent for the PCR amplification of the DNA sample as part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| QZH | Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67125 | Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to determine the risk of developing opioid use disorder (OUD) based on multiple disease-associated genotypes, using a nucleic acid technique (NAT). These genotypes may include, but are not limited to, variants of the methylenetetrahydrofolate reductase (MTHFR), mu-opioid receptor, galanin (GAL) and ABCB1 genes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30850009370250 | GS1 | Pouch | 4 | In Commercial Distribution | |
| Primary | 10850009370256 | GS1 |
Customer Contacts
- Phone
- 1-760-477-2248
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P230032 | 002 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – -15 Degrees Celsius