Kit Labeling, Printing & Packaging Design
The printed parts of a kit are regulated parts of a kit. Boxes, requisition forms, specimen labels and return mailers, designed to the rule, printed in-house, and verified at assembly.
In-house
Design & Print
ISO 13485
Certified Facility
100%
Barcode-Verified Assembly
Six printed components, each with a rule behind it
Every kit carries printed parts that have to be correct for the specimen to be accepted and the result to reach the right person.
Kit box & carton artwork
Your brand or ours, on cartons and mailers sized to the components, with the contents and any required marks placed by design rather than by hand at the dock.
Requisition forms
Designed to solicit every element 42 CFR 493.1241(c) requires a laboratory to capture, in a layout the receiving lab can read and key without guesswork.
Specimen & tube labels
Built to the CLSI specimen label standard and the two-identifier rule, on stock that survives freezers, solvents and analyzer racks.
Kit identifier barcodes
One serialized kit ID carried across the box, the requisition, every tube label and the return label, so the pieces reconcile when they come back apart.
Instructions for use
Plain-language collection steps for patient-collected kits, with revision identifiers printed on each insert so an obsolete version cannot ship.
Return shipping materials
Prepaid return labels and mailers carrying the UN3373 mark and proper shipping name at the required sizes, designed in rather than added later.
What a requisition has to solicit under CLIA
A requisition is a regulatory document before it is a piece of paper. 42 CFR 493.1241(c) requires the laboratory to ensure its test requisition solicits eight categories of information. A form that misses one leaves the receiving lab to chase it, or to reject the specimen.
- 1The name and address, or other suitable identifier, of the authorized person requesting the test and, where appropriate, the individual responsible for using the results, including a contact for reporting life-threatening or panic values
- 2The patient's name or unique patient identifier
- 3The patient's sex and age or date of birth
- 4The test or tests to be performed
- 5The source of the specimen, when appropriate
- 6The date and, if appropriate, time of specimen collection
- 7For Pap smears, last menstrual period and any previous abnormal report, treatment or biopsy
- 8Any additional information relevant and necessary for a specific test, such as fasting status or medications
A note on what this does and does not mean: CLIA certificates are issued to laboratories, not to forms or the companies that print them, and the duty to ensure the requisition solicits these elements sits with the laboratory. DS2 designs forms to solicit all eight and to support your lab's compliance. The order must still come from an authorized person under state law, which for direct-to-consumer kits means the form has to capture whoever that is in each state.
A label that gets read by a person, an instrument and a freezer
Tube labels fail in three ways: wrong content, wrong placement, wrong material. The standards cover all three.
CLSI AUTO12-A
CLSI's specimen label standard fixes a 2 by 1 inch (50.8 by 25.4 mm) label, reserves the top-left line for the patient name as the single most important identification element, sets barcode location and size, specifies a sans serif font at a minimum size, and requires the label applied lengthwise along the tube so people and automated instruments can both read it.
The rule behind the layout
The Joint Commission requires at least two patient identifiers when collecting specimens and labeling in the patient's presence. CAP checklist item GEN.40491 requires two patient-specific identifiers on every primary container, which may be machine-readable. The label has to carry both, legibly, every time.
Code 128 on tubes, Data Matrix where space is tight
Linear Code 128 is what CLSI specifies for tube labels read by clinical analyzers and it reads reliably on a curved tube. Two-dimensional Data Matrix packs more into a small square with built-in error correction, which suits cryovials and small components. Print quality is verifiable against ISO/IEC 15416 and 15415.
Thermal transfer, not direct thermal
Direct thermal stock stays chemically active after printing, so heat, sunlight and solvents darken or fade it. Fine for a parcel label, wrong for a specimen that may sit in a hot vehicle or a freezer for months. Specimen labels are specified as thermal transfer on synthetic stock, which resists heat, moisture, abrasion and chemicals.
Cryogenic-rated stock for frozen tubes
General-purpose adhesives stiffen in a freezer and cannot bond through frost. Frozen and long-term specimens use label stock the manufacturer rates for -80C freezers and liquid nitrogen, applied before freezing unless the stock is specifically rated for frozen surfaces.
Labeling controls are a regulation
Under the FDA Quality Management System Regulation at 21 CFR 820.45, in force since February 2026, labeling and packaging have to stay intact and legible through processing, storage and distribution. A label that lifts in transit is a quality-system failure, not a cosmetic one.
Temperature ratings for label stock are set by the label manufacturer, not by a standard, so they are specified per material. The order the tubes are filled in matters as much as how they are labeled: see the order of draw guide.
One identifier, everywhere
A kit leaves as one object and comes back as several: a tube in a bag, a form in an envelope, a box that may or may not still be attached. The design pattern that survives that is a single serialized kit identifier printed on the outer box, the requisition, every tube label, the biohazard bag and the return label, so the receiving lab can reconcile the pieces without reading handwriting.
Lot number and expiry print as variable data at assembly, from the components actually placed in that kit, rather than from a template. For device kits the same mechanics carry the unique device identifier as a GS1 DataMatrix or linear barcode to your labeler data; the regulatory side of UDI is covered on the medical device & IVD kitting page.
Branded on the way out, compliant on the way back
Outbound packaging is where the brand lives: your artwork on the carton and mailer, consumer-friendly instructions for at-home kits, and white-label configurations for direct-to-consumer testing brands. The return leg is where the regulation lives. A specimen coming back generally ships as Biological Substance, Category B, so the return mailer has to carry the UN3373 mark at the required size and the proper shipping name, and the whole packout has to meet the triple-packaging rule. Designing that in at the artwork stage is cheaper than adding it at the dock, and it is the only way to be sure every kit ships with it.
Packaging specifications are in the UN3373 guide. A two-page overview of the design and print program is available as a PDF: Custom Kitting, Printing & Design.
Artwork as controlled content
Printed parts are handled the way any other kit component is: specified, approved, versioned and verified.
Want to see the print quality first? Request a sample kit.
Design & template
Dielines, label sizes and form layouts built to the kit's components, the receiving laboratory's acceptance policy and the applicable standards, with your branding applied.
Proof & approval
Artwork is proofed against your released specification and signed off before anything prints. Every approved version carries a revision identifier.
Print & variable data
Static artwork prints in-house. Kit identifiers, lot numbers and expiry dates print as variable data at assembly, so each kit carries the data for what is actually inside it.
Verified placement
Labels are applied and barcode-verified at the station, and obsolete versions are purged from the line, so a superseded form or label cannot ship.
Kit printing and labeling questions
What has to be printed for a specimen collection kit?
Six things, typically: the kit box or carton artwork, the requisition form, the specimen and tube labels, a kit identifier barcode carried across the components, instructions for use where the patient collects the sample, and the return shipping label and mailer marks. Treating them as controlled parts of the kit rather than as marketing collateral is what keeps them accurate.
What does a laboratory requisition form have to include?
Under CLIA, 42 CFR 493.1241(c) requires the laboratory to ensure its test requisition solicits eight categories of information: the identity of the authorized person ordering the test and where to report results, the patient's name or unique identifier, sex and age or date of birth, the tests requested, the specimen source when appropriate, the date and time of collection, the additional Pap smear history where relevant, and any further information a specific test needs for accurate testing and interpretation. DS2 designs requisitions to solicit all eight.
Can a requisition form be CLIA-certified?
No. CLIA certificates are issued to laboratories, not to forms, kits, printers or vendors, and the regulation places the duty to ensure the requisition solicits the required elements on the laboratory itself. A form can be designed to solicit everything 493.1241(c) lists and to support your laboratory's compliance, which is what DS2's forms do. Ordering must also actually come from an authorized person under state law, which no form can guarantee on its own.
Is there a standard for specimen tube labels?
Yes. CLSI AUTO12-A, Specimen Labels: Content and Location, Fonts, and Label Orientation, is the current standard and is recognized by FDA. It standardizes a 2 by 1 inch label, puts the patient name in the top-left corner, fixes barcode placement and font rules, and requires lengthwise application so automated instruments can read the label in a rack. CLSI PRE01 covers the patient and specimen identification workflow around it.
What is the difference between thermal transfer and direct thermal labels?
Direct thermal labels print by heating a coated stock with no ribbon, and the coating stays chemically active, so heat, sunlight and solvents darken or fade them over time. Thermal transfer prints ribbon ink onto a synthetic stock and produces an image that resists heat, moisture, abrasion and chemicals. Shipping labels can be direct thermal. Specimen labels that may spend months in a freezer or an archive should be thermal transfer.
Does DS2 produce private-label or white-label kits?
Yes. Direct-to-consumer and at-home testing brands get their own brand on the box, the instructions and the return mailer, built to the same standards as everything else DS2 assembles. One note worth stating plainly: the testing laboratory behind a private-label kit still has to be CLIA-certified for the tests it runs, and the requisition still has to capture whoever the authorized ordering person is in each state.
Can DS2 print UDI barcodes on device kits?
Yes, as production mechanics. A finished convenience kit carries its own unique device identifier on its label, and DS2 can print the GS1 DataMatrix or linear carrier to your labeler data as variable data at assembly. The identifier itself, and the GUDID record behind it, remain your obligation as the labeler; we print to your data and can submit it under your account at your direction. The regulatory detail is on the medical device and IVD kitting page.
References
- 1.42 CFR 493.1241 (CLIA, Standard: Test request): the eight categories of information a laboratory must ensure its test requisition solicits, and the rules on authorized persons and oral requests.
- 2.42 CFR 493.1242(a)(3) (CLIA): laboratories must have written policies for specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source.
- 3.CLSI AUTO12-A, Specimen Labels: Content and Location, Fonts, and Label Orientation (2011): the specimen label standard, recognized by FDA as a consensus standard.
- 4.The Joint Commission, National Patient Safety Goal NPSG.01.01.01: at least two patient identifiers when collecting specimens; containers labeled in the presence of the patient.
- 5.College of American Pathologists, Laboratory General Checklist GEN.40491: all primary specimen containers labeled with at least two patient-specific identifiers, which may be machine-readable.
- 6.GS1 General Specifications (Release 26.0, 2026): Code 128 (ISO/IEC 15417) and Data Matrix (ISO/IEC 16022) symbologies; print quality verification per ISO/IEC 15416 and 15415.
- 7.21 CFR 820.45 (Quality Management System Regulation, effective February 2, 2026): device labeling and packaging controls.
- 8.49 CFR 173.199: UN3373 Biological Substance, Category B marking and packaging requirements for the return leg. See the DS2 UN3373 guide.
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