International Medical Devices Database

Manufacturer Address
Stanbio Laboratory, LP, 1261 N Main St, Boerne TX 78006-3014
Manufacturer Parent Company (2017)
EKF Diagnostics Holdings Plc
Source
USFDA
1 Event
- Recall of Device Recall RF Latex Reagent

One device in the database

Device Recall RF Latex Reagent

Model / Serial
Lot 21675
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - United States nationwide , Canada, Korea, Mexico, Trinidad
Product Description
RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) || RF Latex (1156-001, Control# 172224 expiry 2019-12-31) || RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) || Product Usage: || RaPET¿ RF is intended for the qualitative and semiquantitative detection of rhematoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Stanbio Laboratory, LP

One device in the database

Device Recall RF Latex Reagent