IVD & Lab Instruments

FDA Sets New IVD Traceability Rule for China Exports

FDA sets new IVD traceability rule for China exports: learn how EBTS, batch records, and compliance readiness may impact U.S. customs clearance, delivery timing, and market access.

Diagnostic Service Capacity Cost: What Drives Pricing and When It Becomes a Bottleneck

Diagnostic service capacity cost explained: discover what drives pricing, when weak support becomes a bottleneck, and how to reduce downtime risk before equipment approval.

FDA Sets 72-Hour IVD Export Response Rule

FDA sets a 72-hour IVD export response rule for Chinese manufacturers. Learn how this guidance may affect customs clearance, registrations, submissions, and distributor compliance screening.

FDA Sets 72-Hour IVD Document Reply Rule

FDA Sets 72-Hour IVD Document Reply Rule: learn how the new FDA requirement affects Chinese IVD exporters, review timing, customs clearance, and distributor trust—and what companies should do now.

FDA Tightens Pre-Shipment Review for China LDT IVD Exports

FDA Tightens Pre-Shipment Review for China LDT IVD Exports: learn how the new 72-hour FDA Gateway filing rule affects compliance, shipping timelines, and U.S. export readiness.

How to Evaluate IVD Equipment for Accuracy, Throughput, and Lab Fit

IVD equipment evaluation starts with accuracy. Learn how to compare throughput, workflow fit, consumables, and service support to choose the right system for reliable lab performance.

FDA Opens LDT Pre-Review Path for IVD Exports

FDA Opens LDT Pre-Review Path for IVD Exports: learn how the new 72-hour filing rule affects Chinese IVD exporters, U.S. lab sales, and CBP customs clearance risk.

FDA LDT Rule Sets 60-Day Registration Window

FDA LDT Rule Sets 60-Day Registration Window: learn how the new FDA LDT rule affects IVD exporters, OEM supply models, and U.S. lab compliance—and what actions to take now.

LIMS for Hospital Laboratory: Key Functions That Improve Workflow Visibility

LIMS for hospital laboratory selection starts with workflow visibility. Explore key functions that improve tracking, traceability, turnaround time, and smarter hospital lab decisions.

How to Compare Plastic Laboratory Consumables for Accuracy and Contamination Control

Plastic laboratory consumables comparison guide for labs seeking better accuracy and contamination control. Learn what to check in materials, fit, cleanliness, and supplier quality.