Devices

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.
Manufacturer
Stanbio Laboratory, LP
1 Event
- Recall of Device Recall RF Latex Reagent

Manufacturer

Stanbio Laboratory, LP

Manufacturer Address
Stanbio Laboratory, LP, 1261 N Main St, Boerne TX 78006-3014
Manufacturer Parent Company (2017)
EKF Diagnostics Holdings Plc
Source
USFDA

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