Diagnostic
Diagnostic products, designed, built, and delivered by one partner
As a full-service CDMO, Alentra supports in vitro diagnostic, point-of-care, and laboratory programs from product design and DFM through injection and blow molding, cleanroom manufacturing, assembly, packaging, and logistics, so your products move from first design to finished product without changing partners.
Diagnostic
Diagnostic products, designed, built, and delivered by one partner
As a full-service CDMO, Alentra supports in vitro diagnostic, point-of-care, and laboratory programs from product design and DFM through injection and blow molding, cleanroom manufacturing, assembly, packaging, and logistics, so your products move from first design to finished product without changing partners.
WHERE CONSISTENCY COUNTS
Components every result depends on.
Diagnostic programs depend on consistent, high-volume production. Alentra connects engineering, injection and blow molding, micro molding, cleanroom manufacturing, and automated assembly to deliver cartridges, bottles, labware, and consumables that perform the same way, run after run.
Built for volume
Automated, repeatable processes built for high-volume single-use consumables.
Controlled cleanroom manufacturing
ISO Class 7 and 8 cleanroom molding, assembly, and kitting.
Ready for reagent loading
Components and assemblies prepared for downstream reagent loading and final assembly.
PRODUCTS WE'VE MADE
Components and products built for diagnostic programs.
Examples spanning diagnostic cartridges, reagent and centrifuge bottles, microfluidic chips, and sample collection devices.
Diagnostic cartridges
Centrifuge & reagent bottles
Labware & vials
Microfluidic chips
Sample collection devices
Test kits & single-use consumables
Diagnostic cartridges
Precision for complex diagnostic platforms. Alentra has produced diagnostic cartridges with tight-tolerance molding and controlled assembly.
- Design refinement and DFM
- Tight-tolerance injection molding
- Manual and automated assembly
- Cleanroom manufacturing
Centrifuge & reagent bottles
Consistent containers at scale. Alentra produces centrifuge and reagent bottles with blow molding technologies built for repeatable production.
- Extrusion, injection, and injection stretch blow molding
- Fully programmable process controls
- Design for part-to-part consistency
- ISO Class 8 cleanroom production
Labware & vials
Reliable labware for everyday testing. Alentra manufactures labware and vials for diagnostic and laboratory use.
- Injection and blow molding
- Statistical process control
- Cleanroom production when required
- Labeling and packaging
Microfluidic chips
Precision at the smallest scale. Alentra manufactures microfluidic chips to exact specifications, supported by micro molding expertise.
- Micro molding for miniature, tight-tolerance features
- Material selection expertise
- Tool design and fabrication
- Vision inspection for small features
Sample collection devices
Designed for easy, reliable collection. Alentra developed and produced an easy stool extraction device, combining molding and advanced prototyping.
- Design and DFM support
- Advanced prototyping
- Injection molding
- Assembly and packaging
Test kits & single-use consumables
Consistency at high volume. Alentra produces diagnostic test kits and single-use consumables with automated, repeatable processes.
- Tight-tolerance injection molding
- Pellet-to-pallet automation
- Statistical process control and vision inspection
- Kitting and cleanroom packaging
HOW WE BUILD IT
The capabilities behind your device
Specialized capabilities working together from design through high-volume production and delivery.
Blow Molding
EBM, IBM, and ISBM for centrifuge bottles, reagent bottles, and vials.
Injection Molding
Tight-tolerance molding for cartridges and consumables.
Specialty & Micro
Micro molding and microfluidic chip manufacturing.
Cleanroom Manufacturing
ISO Class 7 & 8 environments for diagnostic components.
Automation & Assembly
Automated assembly, welding, and bonding at high volume.
Packaging & Kitting
Labeling, RFID, and kitting ready for reagent loading.
QUALITY & COMPLIANCE
Quality systems built for regulatory confidence.
In diagnostics, consistency has to be proven. Our ISO 13485 quality management system, FDA registration, validation services, and inspection capabilities provide documented support from development through production.
- ISO 13485:2016 quality management system
The core medical-device quality standard, applied across our operations. - FDA registered
Supporting regulated diagnostic production. - IQ / OQ / PQ validation services
Process validation and capability studies integrated into development. - Statistical process control & inspection
Full SPC, vision and inline inspection, and weekly reporting on corrective actions.
Ready to move your next diagnostic program forward?
Whether you're developing a new cartridge, scaling consumables, or launching a point-of-care product, we'll bring together the expertise and capabilities your program needs for its next stage.
Locations
U.S. capacity,
coast to coast.
With manufacturing and warehousing across the East and West Coasts, Alentra gives diagnostic programs access to domestic capacity closer to the markets they serve. Our U.S. footprint supports molding, cleanroom manufacturing, assembly, packaging, and logistics, helping keep high-volume programs moving.
6
Manufacturing Facilities
7
ISO-certified cleanrooms
167
Molding Machines
5
Coast-to-coast Warehouses
EXPLORE MORE
Related markets
Life Science
Pipettes, blood-testing components, media bottles, and bioprocess single-use systems and consumables.
Medical Device
Class I, II, and III device components, including stents, delivery systems, single-use devices, and finished assemblies.
Pharmaceutical
Ophthalmic bottles, dropper tips, dosing containers, and closures manufactured for pharmaceutical primary packaging.
Drug Delivery
Autoinjector pens, drug-delivery devices, and single-use consumables manufactured with the precision, repeatability, and scale these programs demand.
Ready to move your program forward?
Whatever your market or stage of development, Alentra brings together the expertise, quality systems, and manufacturing capabilities needed to move your program from concept through production.