Specimen Collection Kits & Consumables
Pre-configured and custom specimen collection kits for labs and testing programs, with a managed consumable supply behind them that keeps every component in date and traceable to the kit lot.
20M+
Kits Built Annually
200+
Vetted Component Suppliers
<0.01%
Defect Rate
Lab kitting supplies are not laboratory supplies
Laboratory supplies is a distributor category: tubes by the case, swabs by the box, bought from a catalog and stored until needed. Lab kitting supplies are something else. They are the components that go into a configured collection kit, sourced from vetted suppliers, lot-tracked and expiry-managed, assembled to a specification and delivered as a finished kit or as a managed supply to a draw site.
DS2 is a kitting service rather than a distributor. The value is in the configuration, the traceability, and in keeping every component in date, which turns out to be the part that most often goes wrong.
What is in the box, and why
Six components, most of them regulated in their own right. A kit of two or more devices packaged together is itself a device, which is why the assembler has to be FDA-registered.
| Component | What it is and what governs it |
|---|---|
| Collection device | Evacuated tubes by additive, needle or winged set and holder, swab, urine container or saliva device. Tubes and blood collection devices are regulated devices in their own right (21 CFR 862.1675, Class II). |
| Transport medium | Where the sample type needs it: viral or universal transport media, culture transport systems. Transport media are FDA-regulated devices with an expiration date and a lot number on the label. |
| Primary and secondary containment | A leak-proof primary receptacle inside a secondary container with enough absorbent material for the full liquid volume, which is what the Category B rules require. |
| Requisition and labels | A requisition designed to solicit what CLIA requires, and specimen labels built to the CLSI label standard, both printed in-house and carrying the kit identifier. |
| Instructions | Collection steps for the collector, or plain-language patient instructions for at-home kits, with a revision identifier on each insert. |
| Outer packaging and return mailer | A rigid outer package, and for the return leg the UN3373 mark and proper shipping name at the required sizes, designed into the kit rather than added at the dock. |
Requisitions and labels are covered in depth on the kit labeling, printing & packaging design page; the tube sequence at collection is in the order of draw guide.
Kits by sample type and program
Standard configurations for the common sample types, each customizable to the receiving laboratory's specification.
Venous blood
Tube sets by additive, matched to the assay and to the order of draw, with holders, needles or winged sets, prep pads and gauze as the program requires.
Urine
Sterile cups, preservative tubes and transfer devices for culture, chemistry and drug-testing programs, with tamper-evident options where the program needs them.
Saliva and oral fluid
Collection devices and stabilizing buffers for genomic, hormone and drug-testing assays, sized for patient self-collection.
Swab and molecular
Nasal, nasopharyngeal, throat and other swabs with the transport medium the assay is validated on, held and shipped within the medium's labeled temperature range.
Stool and specialty
Fecal collection with preservative or transport medium, plus tissue, dried blood spot and other specialty configurations built to the receiving lab's specification.
At-home and DTC
Patient-facing kits for direct-to-consumer brands: consumer-friendly packaging, clear instructions, return shipping materials, and your brand on the box.
Running a study? See clinical trial kitting. Building a consumer testing product? See direct-to-consumer testing.
Keeping every component in date
The part of kit supply nobody puts on a product page, and the part a lab is actually inspected on.
Consumables expire, and expired ones cannot be used
Under CLIA, 42 CFR 493.1252(d), reagents, media and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. CAP's All Common Checklist (COM.30400) requires reagents, chemicals and media used within their indicated expiration date. A kit that arrives at a draw site with a short-dated tube is a rejection waiting to happen.
The vacuum and the additive both age
BD's Vacutainer instructions list tube age among the factors that change the quantity of blood drawn, warn that under- or overfilling produces an incorrect blood-to-additive ratio that may lead to incorrect results, and state plainly: do not use tubes after their expiration date. Greiner's instructions warn that exceeding the recommended storage temperature (25C) may impair tube quality, including vacuum loss and drying out of liquid additives.
First expired, first out
Component lot and expiry are captured at receiving, kits are built and shipped first-expired-first-out, and an agreed minimum remaining shelf life at dispatch stops a kit arriving with weeks left on it.
A kit lot is a record of every component lot
Each finished kit lot records the lot of every tube, swab, medium and label inside it, so a component recall can be traced forward to the kits and sites it reached rather than triggering a blanket withdrawal.
When a component back-orders
Supplier back-orders happen. Under DS2's ISO 13485 quality system a substitution goes through documented change control, an equivalence check against the specification, and customer notification before it ships, rather than a quiet swap on the line.
Managed supply for draw sites
Standing orders and managed replenishment keep collection sites in date without ad hoc purchasing, whether the site takes finished kits or a managed supply of tubes, swabs, media and shipping materials for its own collection.
Shelf lives are set by each component manufacturer and vary by product, which is why they are managed per lot rather than assumed. Warehousing, distribution and the 3PL side of the program are on the kitting, fulfillment & distribution page.
Configured, traced and in date, from one accountable partner
DS2 builds more than 20 million kits a year in an FDA-registered, ISO 13485:2016 and ISO 9001 certified, temperature-controlled facility, sourcing through more than 200 vetted suppliers, with 100% barcode-verified assembly, defect rates below 0.01%, and full lot traceability and recall capability. FDA registration means the establishment is listed with FDA and open to inspection; it is not FDA approval of the facility or of any kit, a distinction a quality director will check.
Because the same partner designs the custom kit, prints the labels and requisitions, holds the inventory, and moves the specimen back by medical courier, the consumables inside the box and the packaging around it are specified together, within each component's labeled temperature range.
Specimen kit and consumables questions
What is in a specimen collection kit?
A collection device matched to the sample type and assay (tubes by additive, swab, urine container or saliva device), a transport medium where the sample needs one, a leak-proof primary receptacle inside a secondary container with absorbent material, a requisition form and specimen labels, instructions for the collector or patient, and a rigid outer package with compliant return shipping materials. The exact configuration follows the receiving laboratory's specification.
What is the difference between lab kitting supplies and laboratory supplies?
Laboratory supplies is a distributor category: catalog items bought by the case. Lab kitting supplies are the components that go into a configured collection kit, sourced, lot-tracked, expiry-managed and assembled to a specification, then delivered as a finished kit or as a managed supply to a draw site. DS2 is a kitting service, not a distributor; the value is in the configuration, the traceability and keeping everything in date.
Why do blood collection tubes have expiration dates?
Because the draw depends on the tube's stored vacuum and on the ratio of blood to additive. BD's instructions list tube age among the factors that affect the quantity of blood drawn, warn that an incorrect blood-to-additive ratio may lead to incorrect results, and state that tubes must not be used after their expiration date. Storage conditions matter too: Greiner warns that exceeding the recommended 25C storage maximum may cause vacuum loss and drying out of liquid additives.
Can a laboratory use collection supplies past their expiration date?
No. CLIA at 42 CFR 493.1252(d) requires that reagents, media and other supplies not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality, and CAP's All Common Checklist (COM.30400) requires reagents, chemicals and media used within their indicated expiration date. That is why expiry-managed, first-expired-first-out supply matters more than the price of the box.
Is a specimen collection kit a medical device?
A kit of two or more different medical devices packaged together for the convenience of the user is a convenience kit and is treated by FDA as a device in its own right, which is why the kit assembler must be FDA-registered. Individual components are devices too: blood collection tubes and devices are Class II, and microbiological specimen collection and transport devices, including viral transport media, are Class I. DS2 is an FDA-registered establishment and assembles under an ISO 13485:2016 certified quality system.
Does DS2 offer standard kits or only custom configurations?
Both. Common configurations for blood, urine, saliva, swab and stool collection are built to standard specifications, and any configuration can be customized to the receiving laboratory's requirements, including custom components, labels, requisitions and branding. Volumes run from pilot quantities to hundreds of thousands of kits.
Can DS2 supply consumables without full kitting?
Yes. Draw sites and programs that collect with their own staff can take a managed supply of tubes, swabs, transport media, biohazard bags and shipping materials, lot-tracked and rotated first-expired-first-out, with standing orders so sites stay in date without ad hoc purchasing.
References
- 1.42 CFR 493.1252(d) (CLIA, Standard: Reagents, culture media, and supplies): reagents, media and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality.
- 2.College of American Pathologists, All Common Checklist COM.30400 (Reagent Expiration Date): all reagents, chemicals, and media are used within their indicated expiration date.
- 3.BD Vacutainer venous blood collection tubes, instructions for use: tube age affects the quantity of blood drawn; incorrect blood-to-additive ratio may lead to incorrect analytic results; do not use tubes after their expiration date.
- 4.FDA, FAQs on viral transport media: most viral transport media are Class I devices under 21 CFR 866.2390, subject to the quality system regulation and to IVD labeling requirements including expiration date and lot number.
- 5.21 CFR 801.3: a convenience kit is two or more different medical devices packaged together for the convenience of the user. 21 CFR 862.1675 (blood specimen collection device, Class II) and 866.2900 (microbiological specimen collection and transport device, Class I).
- 6.49 CFR 173.199: Category B triple packaging, absorbent material and the UN3373 mark for the return leg. See the DS2 UN3373 guide.
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