Identity
- Trade Name
- Liquichek FDA UDI
- Generic Name
- Treponema pallidum reagin antibody IVD, control FDA UDI
- Device Name
- Liquichek ToRCH Plus Control, Positive (An unassayed (human) Serology control.) FDA UDI
- Model / Reference
- 239 FDA UDI
- Description
- Liquichek ToRCH Plus Control, Positive (An unassayed (human) Serology control.) FDA UDI
Identifiers
- Catalog Number
- 239 FDA UDI
- Primary DI / UDI-DI
- 00847661000235 FDA UDI
- FDA Product Code
- OHQ FDA UDI
- GMDN Term
- Treponema pallidum reagin antibody 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Multiple infectious organism/newborn TORCH screen IVD, controlVaricella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, controlTreponema pallidum reagin antibody IVD, controlHelicobacter pylori immunoglobulin G (IgG) antibody IVD, control
Liquichek by Bio-Rad Laboratories — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
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
- Bio-Rad Laboratories
Sources (1)
- FDA UDI fe09d755-34ab-4f05-b0b7-8fd7827f0378 36 fields · synced May 30, 2026