Identity
- Trade Name
- Buffer AVL (w/o carrier RNA, 155 ml) FDA UDI
- Generic Name
- Nucleic acid sequencing reagent kit IVD FDA UDI
- Device Name
- Viral Lysis Buffer FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Viral Lysis Buffer FDA UDI
Identifiers
- Catalog Number
- 19089 FDA UDI
- Primary DI / UDI-DI
- 04053228039150 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Nucleic acid sequencing reagent kit IVD FDA UDI
- Models / Variants
- w FDA UDIo carrier RNA FDA UDI155 ml 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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 (w +2 more) by Qiagen, Inc. — Class I — FDA UDI — listed in FDA GUDID — 3 models — regulatory data on deviCERTS
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Also classified as Nucleic acid sequencing reagent kit IVD.
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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 |
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Manufacturer
- Manufacturer
- Qiagen, Inc.
Sources (1)
- FDA UDI 66e98412-cbc9-4b01-a543-1ca864713892 35 fields · synced May 30, 2026