Kitting, Fulfillment & Distribution
A regulated 3PL for diagnostics. DS2 assembles, warehouses, and ships your kits from an FDA-registered, ISO 13485 facility, the medical alternative to generic ecommerce fulfillment.
20M+
Kits Built Annually
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On-time Fulfillment
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Kitting and fulfillment, built for regulated goods
Kitting is assembling separate components into a single ready-to-ship kit. Fulfillment is storing, picking, packing, and shipping those kits on demand. Put them together and one partner builds the kits, holds them in inventory, and ships them, individually to a patient or in bulk to a site, without the customer touching a box. This is the fulfillment and distribution side of DS2's custom kitting program.
Search for a kitting-and-fulfillment 3PL and nearly every result is built for ecommerce: subscription boxes, retail bundles, promotional inserts. Diagnostic and medical kits are a different problem. The components expire, some need refrigeration, the finished kit is a regulated device, and the specimen has to come back safely. That is the gap DS2 fills.
One operation, end to end
Assembly, on-demand fulfillment, and distribution in both directions, under one accountable roof.
Assembly into a finished kit
Separate components (tubes, swabs, transport media, requisition forms, packaging) assembled and quality-controlled into a single ready-to-use kit with its own finished-goods SKU.
Stored, picked, packed, shipped
Kits held in inventory and shipped on demand, individually to a patient's home or in bulk to a collection site, with barcode-verified picking and same-day turnaround.
Out to the field and back
Forward distribution to providers, sites, and patients, plus reverse logistics for specimen returns and kit replenishment, integrated with DS2's own courier network.
What a regulated 3PL does that a generic one does not
A generic ecommerce 3PL ships boxes. Diagnostic kit fulfillment carries obligations that a warehouse built for retail was never set up to meet.
FDA-registered kit assembler
Assembling components into a specimen collection kit creates a finished device in its own right. Under 21 CFR Part 807, the kit assembler must register with FDA and list the kit. DS2 operates as an FDA-registered establishment, not a generic warehouse that happens to ship medical goods.
ISO 13485:2016 quality system
The medical device quality management standard covers storage and distribution, not just manufacturing. DS2 runs kitting, storage, and distribution inside that system, with controlled work instructions, build records, and CAPA behind every kit.
Lot traceability & recall readiness
Component lot numbers are recorded against each finished kit, so a specific lot can be traced, quarantined, and recalled. Generic 3PLs track a marketing SKU; a regulated program tracks the lot.
Expiry management & FEFO
Diagnostic components are date-controlled. Stock is rotated and picked first-expired-first-out, in line with WHO good distribution practice, so kits reach the end user with usable shelf life rather than expiring on a shelf.
Temperature-controlled storage
Reagents and biological components are stored and shipped within each product's labeled temperature range, with monitoring, rather than assuming everything is ambient-stable.
Compliant specimen returns
Return shipping of diagnostic specimens follows the UN3373 Category B rules (triple packaging, Packing Instruction 650), designed into the kit rather than improvised at the mailbox.
A note on accuracy: DS2's FDA-registered status comes from acting as a kit assembler, which makes the finished kit a device, not from distribution alone. Kits are assembled under a quality system aligned to ISO 13485; DS2 does not claim any kit is “FDA approved.”
From components to the field
A controlled flow from intake to distribution, with quality and traceability at each step.
Running a clinical study? See clinical trial kitting.
Receive & Inspect
Incoming components are received against specification and inspected, with lot numbers and expiry dates captured into inventory at intake.
Build & QC
Kits are assembled to a validated bill of materials in an ISO 13485 environment, with barcode verification and quality control at every station.
Label & Store
Finished kits are labeled and held in temperature-appropriate, inventory-managed storage under first-expired-first-out rotation.
Fulfill & Distribute
Orders ship same-day, individually to patients or in bulk to sites, through the DS2 courier network or integrated carriers, with returns handled as a managed flow.
Fulfillment that connects to the rest of the chain
The advantage of a regulated 3PL that is also a diagnostic-support company is that the seams disappear. The same partner that assembles and stores the kit also moves it by temperature-controlled courier, packs it to the UN3373 Category B standard for the specimen's return, and holds it within its labeled temperature range. One accountable operator from component to result, rather than a chain of vendors pointing at each other.
Kitting, fulfillment & 3PL questions
What is kitting and fulfillment?
Kitting is assembling separate components into a single ready-to-ship kit with its own SKU. Fulfillment is storing, picking, packing, and shipping those kits on demand. Together, one partner builds the kits, holds them in inventory, and ships them, individually to patients or in bulk to sites, without the customer handling the logistics.
What is the difference between kitting and assembly?
Assembly is the hands-on step of physically combining components into the finished unit. Kitting is the broader service of grouping items into a defined kit, assigning it a new SKU, and managing it through storage and fulfillment. In practice the two are done together, which is why the service is often called kitting and assembly.
What is a 3PL, and how is a regulated 3PL different?
A third-party logistics provider (3PL) performs logistics functions on your behalf: warehousing, inventory, pick and pack, fulfillment, and distribution, with kitting as a value-added service. A regulated 3PL for diagnostics adds what a generic ecommerce 3PL does not: FDA establishment registration as a kit assembler, an ISO 13485 quality system over storage and distribution, lot traceability, expiry and FEFO control, temperature control, and compliant specimen-return shipping.
Is assembling a specimen collection kit an FDA-regulated activity?
Yes. FDA treats a convenience kit as a medical device in its own right, so the kit assembler must register as a device establishment and list the kit (21 CFR Part 807). That is different from simply distributing finished devices, which is often exempt. DS2's FDA-registered status comes from acting as a kit assembler, not merely a shipper.
Can DS2 handle expiry-dated and temperature-sensitive components?
Yes. Dated components are managed with lot and expiry tracking and picked first-expired-first-out, in line with WHO good distribution practice. Temperature-sensitive reagents and biologicals are stored and shipped within each product's labeled range with monitoring, not treated as ambient stock.
Does DS2 handle reverse logistics for specimen returns?
Yes. Return shipping is designed into the kit, with UN3373 Category B compliant packaging for the specimen coming back, and kit replenishment managed as part of the same program rather than as a separate problem.
References
- 1.21 CFR 807.20: establishments that manufacture, assemble, repackage, or relabel a device must register and list. FDA treats a kit assembler as a device manufacturer (distinct from an exempt distributor of finished devices).
- 2.FDA, Convenience Kits Interim Regulatory Guidance: a convenience kit is a medical device in its own right; the kit assembler must register and list, with enforcement discretion on premarket notification for kits of legally marketed components.
- 3.ISO 13485:2016, Medical devices, Quality management systems: scope covers organizations in life-cycle stages including production, storage, and distribution.
- 4.FDA Quality Management System Regulation (QMSR), effective February 2, 2026: amends 21 CFR Part 820 to incorporate ISO 13485:2016 by reference.
- 5.WHO Good Storage and Distribution Practices (Technical Report Series No. 1025, Annex 7): batch and expiry records and first-expired-first-out (FEFO) issue of stock.
- 6.IATA Dangerous Goods Regulations, Packing Instruction 650 (UN3373 Biological Substance, Category B); mirrored at 49 CFR 173.199. See the DS2 UN3373 guide.
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