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A urine tube is a small, usually evacuated (vacuum) tube used to collect, transport and store a urine specimen for laboratory testing. The most common kind is the urine culture tube, sometimes called a urine collection tube or C&S (culture and sensitivity) tube, which holds a preservative so bacteria and yeast in the sample stay at their collected level until the laboratory cultures them.
This page describes products and general use; it is not medical advice.
Who uses it: FDA’s decision summary for one culture tube states it is for professional use only and for prescription use only, so these tubes are used by clinic, hospital and laboratory staff.
What a urine tube is
A urine tube is a specimen tube filled with a measured volume of urine. The type reviewed by FDA in 510(k) K163436, the Greiner Vacuette Urine Count and Culture, Mannitol tube, is described as “a urine stabilization device intended for collection, transport and storage of urine for bacterial and yeast culture.” Searches for “urine culture tube” and “urine collection tube” lead to this same product class.
The tube itself does not test anything. The FDA summary says the device “does not provide a result that can be used in making a clinical decision”; the laboratory result comes from the culture performed later.
How a urine tube is built
The FDA record describes the Greiner tubes as made of polyethylene terephthalate (PET) with a pre-defined vacuum to exact draw volumes, fitted with yellow safety caps. They contain a fine particle granulate stabilizer. The predicate device in the same record, the BD Vacutainer Plus Plastic Urine C&S Tube (K024240), is listed in clear plastic and glass with a conventional gray stopper.
- Vacuum: the tube draws a pre-set volume. In Greiner’s shelf-life testing, tubes drew within 10% of the designed fill volume out to 14 months after manufacture.
- Additive: a stabilizer or preservative, listed in the table below, that protects the bacterial level in the specimen.
- Closure: a color-coded cap or stopper (yellow safety cap or conventional gray stopper in the products cited here).
- Sterility: the FDA summary states the Greiner tubes are sold sterile, by e-beam sterilization.
Types of urine tube
The two products compared in the FDA record show how culture tubes differ. Both are preservative tubes for urine culture.
| Feature | Greiner Vacuette Urine CCM (K163436) | BD Vacutainer Plus Plastic Urine C&S (K024240) |
|---|---|---|
| Tube material | Clear plastic (PET) | Clear plastic and glass |
| Additives | Boric acid, sodium formate, sodium borate, mannitol | Boric acid, sodium formate, sodium borate |
| Closure | Safety cap, yellow | Conventional stopper, gray |
| Stated storage before culture | 20-25 °C for up to 48 hours | 48 hours (as listed in the FDA comparison) |
Source: FDA 510(k) Decision Summary K163436 (see Sources).
Urine culture tube
Holds a preservative so the specimen can wait for culture. The two products above are examples.
Other urine tubes
Not every urine tube is a culture tube. Tubes for other tests, and transport tubes for molecular assays, use different contents and are not interchangeable with a culture tube. See urine collection kit contents and tube types for how two named laboratory collection sheets assign tubes to tests.
Sizes that matter
The FDA comparison lists these tube sizes and draw volumes.
| Tube size (diameter x length) | Draw volume | Listed for |
|---|---|---|
| 13 x 75 mm | 4 mL | Greiner CCM; BD Plus Plastic Urine C&S |
| 16 x 75 mm | 5 mL | BD Plus Plastic Urine C&S |
| 16 x 100 mm | 5 mL | Greiner CCM |
| 16 x 100 mm | 10 mL | Greiner CCM; BD Plus Plastic Urine C&S |
BD also lists a Vacutainer Bulk Urine Tube, Culture & Sensitivity Tube (catalog 364951) as 13 x 75 mm with a 4 mL draw volume, boric acid, sodium formate and sodium borate preservative, and a gray conventional closure (BD product page).
How the regulation classifies it
For the Greiner culture tube, FDA recorded the regulation as 21 CFR 866.2390 (Transport Culture Medium), Class I, product codes JSM (Culture Media, Non-Propagating Transport) and LIO (Device, Specimen Collection), reviewed under the Microbiology panel.
A separate regulation, 21 CFR 864.3250 (specimen transport and storage container), covers containers that “may be empty or prefilled” (prefilled with a fixative or general purpose reagent). It is Class I, exempt from 510(k) premarket notification subject to 21 CFR 864.9, and excludes over-the-counter drugs-of-abuse collection systems (CFR text via Cornell LII). Which regulation applies to a given tube is stated in that product’s own FDA record.
How to choose
These criteria come from the FDA record and CFR text listed under Sources.
| Criterion | What the source states |
|---|---|
| Intended use | The Greiner CCM tube is intended for collection, transport and storage of urine for bacterial and yeast culture (FDA K163436). |
| Who may use it | Professional use only; prescription use only (FDA K163436). |
| Storage window | Up to 48 hours at 20-25 °C before culture for the Greiner tube (FDA K163436). BD’s product page for catalog 364951 states no storage time, so none is attached to it here. |
| Draw volume | Tubes are vacuum-set to exact draw volumes: 4, 5 or 10 mL for the Greiner family (FDA K163436). |
| Shelf life | 14 months after manufacture for the Greiner tube (FDA K163436). |
Safe use and handling basics
- Use the tube only for the purpose in its labeling; a culture tube is not a general-purpose container.
- Handle and pack specimens in leakproof, labeled containers; see specimen container requirements and biohazard specimen bags.
Common mistakes
- Treating “urine tube” as one product. A preservative culture tube and a tube for another test are different devices.
- Carrying one product’s 48-hour window over to another brand whose labeling does not state it.
- Assuming the tube gives a result. The FDA summary says the device itself gives none.
FAQ
What is a urine culture tube?
It is a preservative urine tube intended for collecting, transporting and storing urine for bacterial and yeast culture. The Greiner example holds the sample at 20-25 °C for up to 48 hours before culture (FDA K163436).
Is a urine collection tube the same as a urine culture tube?
The names are used for the same class of device in vendor and laboratory language, but a collection tube may be intended for a different test than culture. The tube’s labeling states its intended use.
How is a urine tube regulated?
The Greiner culture tube is Class I under 21 CFR 866.2390; empty or prefilled specimen containers are described in 21 CFR 864.3250, also Class I.
Related pages
For kit contents see the urine collection kit checklist; for the regulatory term see what is an in vitro diagnostic; for clinic stock lists see the urology clinic supply checklist.
Sources
All sources below were checked on 2026-10-30.
- FDA, 510(k) Decision Summary K163436, Greiner Vacuette Urine Count and Culture, Mannitol tube: https://www.accessdata.fda.gov/cdrh_docs/reviews/K163436.pdf
- BD, Vacutainer Bulk Urine Tubes, Culture & Sensitivity Tube, catalog 364951: https://www.bd.com/en-us/products-and-solutions/products/product-page.364951
- 21 CFR 864.3250, Specimen transport and storage container: https://www.law.cornell.edu/cfr/text/21/864.3250
