Identity
- Trade Name
- DBS Controls LysoPC FDA UDI
- Generic Name
- Multiple clinical chemistry enzyme IVD, control FDA UDI
- Device Name
- The DBS Controls LysoPC is intended for use as an external control material to estimate the precision of lysophospatidylcholines C24:0-LysoPC and C26:0-LysoPC measurement in laboratory procedures. This product has no qualitative or quantitative assigned value. This control is not intended for any specific patient population or specimen. FDA UDI
- Model / Reference
- 3413-0010 FDA UDI
- Description
- The DBS Controls LysoPC is intended for use as an external control material to estimate the precision of lysophospatidylcholines C24:0-LysoPC and C26:0-LysoPC measurement in laboratory procedures. This product has no qualitative or quantitative assigned value. This control is not intended for any specific patient population or specimen. FDA UDI
Identifiers
- Catalog Number
- 3413-0010 FDA UDI
- Primary DI / UDI-DI
- 06438147391998 FDA UDI
- FDA Product Code
- OHQ FDA UDI
- GMDN Term
- Multiple clinical chemistry enzyme IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
Yes
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
Yes
FDA UDI
Category: Multiple clinical chemistry enzyme IVD, control
DBS Controls LysoPC by Wallac, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Wallac, Inc.
Sources (1)
- FDA UDI 760c9268-5aa5-4ecf-97e9-efa9048b2825 35 fields · synced May 30, 2026