Identity
- Trade Name
- AvertD™ Buccal Sample Collection Kit FDA UDI
- Generic Name
- Oral/upper respiratory tract specimen collection kit IVD, clinical FDA UDI
- Device Name
- Buccal Sample Collection Kit for use with AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA. FDA UDI
- Model / Reference
- 12-0610-01 FDA UDI
- Description
- Buccal Sample Collection Kit for use with AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA. FDA UDI
Identifiers
- Catalog Number
- 12-0610-01 FDA UDI
- Primary DI / UDI-DI
- 10850009370225 FDA UDI
- PMA Number
- P230032 FDA UDI
- FDA Product Code
- QZH FDA UDI
- GMDN Term
- Oral/upper respiratory tract specimen collection kit IVD, clinical FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Oral/upper respiratory tract specimen collection kit IVD, clinical
AvertD™ Buccal Sample Collection Kit by Autogenomics, Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 895dba6a-3768-489a-9e4d-6fbcb196f31e 37 fields · synced May 30, 2026