Identity
- Trade Name
- AvertD™ (96) AMP Mix FDA UDI
- Generic Name
- Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 03-7560-01 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 03-7560-01 FDA UDI
- Primary DI / UDI-DI
- 10850009370256 FDA UDI
- PMA Number
- P230032 FDA UDI
- FDA Product Code
- QZH FDA UDI
- GMDN Term
- Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT)
AvertD™ (96) AMP Mix by Autogenomics, Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT).
- AvertD™ (96) Tube — AUTOGENOMICS, INC · Class III
- AvertD™ BioFilmChip Microarray Magazine — AUTOGENOMICS, INC · Class III
- AvertD™ Intellipac Reagent Module — AUTOGENOMICS, INC · Class III
- AvertD™ Amplification Mix — AUTOGENOMICS, INC · Class III
- AvertD™ (96) PE Mix — AUTOGENOMICS, INC · Class III
Cleared under the same submission
P230032 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Autogenomics, Inc
Sources (1)
- FDA UDI f2b7cc42-bb4f-43fa-8931-b45a970c6649 37 fields · synced Jun 8, 2026