Identity
- Trade Name
- Buffer AVL FDA UDI
- Generic Name
- Nucleic acid sequencing reagent kit IVD FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Catalog Number
- 19073 FDA UDI
- Primary DI / UDI-DI
- 04053228006442 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Nucleic acid sequencing reagent kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nucleic acid sequencing reagent kit IVD
Buffer AVL by Qiagen, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nucleic acid sequencing reagent kit IVD.
- DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000Dx — Illumina, Inc. · Class I
- Sentosa SQ Sequencing Reagents (8) — VELA OPERATIONS SINGAPORE PTE. LTD. · Class I
- Sentosa SX IA Reagents Kit (8) — VELA OPERATIONS SINGAPORE PTE. LTD. · Class I
- Sentosa ST Template Reagents (8) — VELA OPERATIONS SINGAPORE PTE. LTD. · Class I
- Sentosa SQ 318 Chip Kit (8) — VELA OPERATIONS SINGAPORE PTE. LTD. · Class I
- Sentosa ST Template Supplies (8) — VELA OPERATIONS SINGAPORE PTE. LTD. · Class I
- Sentosa SX IA Solution Kit (8) — VELA OPERATIONS SINGAPORE PTE. LTD. · Class I
- NovaSeq™ 6000Dx S2 Buffer Cartridge — Illumina, Inc. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Qiagen, Inc.
Sources (1)
- FDA UDI 585b13cc-017d-453b-8e6c-82acc64ee1c6 33 fields · synced May 30, 2026