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Tuberculin Needles: Gauge, Length and FDA Class

A tuberculin needle is the needle on a 1 mL tuberculin syringe. See labelled gauge and length examples, FDA codes and what to check in a device record.

Written and maintained by CASRAI Editorial Board

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This page describes products and general use; it is not medical advice.

A tuberculin needle is not a separate needle type. It is the everyday name for the needle on a 1 mL tuberculin syringe: a fine, short needle fitted to a small, finely calibrated syringe. The practical question for a buyer or clinic staff member is which configuration a product label or device record describes, and this page shows what to read to find out.

What a tuberculin needle is

Short answer: “tuberculin needle” usually means the needle supplied with, or fitted to, a 1 mL tuberculin syringe. The name comes from the syringe’s use with tuberculin and similar test allergens.

Who uses it: clinics that use tuberculin or allergy-test syringes, and the buyers who stock them. Allergy and other clinics list the same syringe class on their supply lists, for example in our allergy clinic supply checklist.

FDA does not list a “tuberculin needle” as its own device. In FDA’s own record for a tuberculin syringe, the GMDN term “Tuberculin/allergy syringe/needle, safety” is defined as a sterile device with a calibrated barrel and plunger and an attached needle, intended for precise injection of tuberculin or sensitivity test allergen (AccessGUDID record 00850578007426, checked 1 November 2026). The record also describes it as single-use.

How it is built

Two federal device definitions cover the parts. Both are Class II in FDA’s classification database (openFDA, checked 1 November 2026).

  • The syringe (product code FMF, “Syringe, Piston”, 21 CFR 880.5860): a calibrated hollow barrel and a movable plunger, with a male connector (nozzle) at one end that fits the female connector (hub) of a hypodermic single lumen needle.
  • The needle (product code FMI, “Needle, Hypodermic, Single Lumen”, 21 CFR 880.5570): a metal tube sharpened at one end and joined at the other to a female connector (hub) that mates with the nozzle of a piston syringe or an intravascular administration set.

Both regulations describe the device as used to inject fluids into, or withdraw fluids from, the body.

Configurations as labelled

Short answer: the same 1 mL syringe is sold with the needle permanently attached or with a detachable needle, and with or without a safety shield. Each row below is a labelled configuration traced to a manufacturer page or an FDA record, not a recommendation.

Configuration as labelled Needle attachment Source
1 mL, 27 G x 3/8 in, intradermal bevel, shielding safety mechanism, regular wall Permanently attached BD product page 303327 (BD SafetyGlide Tuberculin Syringe), checked 1 November 2026
1 mL, 25 G x 5/8 in, luer lock, single use Detachable needle AccessGUDID record 00812460026878, GMDN “Tuberculin/allergy syringe/needle, basic”, product codes FMF and FMI
1 mL, 25 G x 5/8 in, GMDN “safety” tuberculin syringe/needle Attached needle (per the GMDN definition) AccessGUDID record 00850578007426, product code FMF

The BD page also lists a 1 mL fill volume and describes the product as a single-use disposable product.

25 G syringes and hypodermic needle sizes

A “25 syringe” search usually means a 25 gauge needle on a small syringe. The two records above show 25 G x 5/8 in as a labelled tuberculin configuration, and the BD page shows 27 G x 3/8 in. Gauge is a number that rises as the needle gets thinner. For the full gauge-to-diameter table, see the bigger the gauge, the smaller the needle, and for related fixed charts see insulin pen needle sizes and blood draw needle size. This page does not repeat those tables.

For volume markings on small syringes, see our 1 cc and mL explainer.

How to verify a listing before you rely on the name

Short answer: read the device record, not the product name. FDA’s records show that the same name can be filed differently: one tuberculin syringe is coded FMF (syringe only), another FMF plus FMI (syringe with detachable needle), and a product named “1ml Tuberculin Suresafe Syringe” (record 05391530750219) is coded under GMDN “Metered-delivery hypodermic syringe/needle”, product code MEG.

Fields to read in an AccessGUDID record or the maker’s instructions for use:

  • Fill volume (for example 1 mL), needle gauge and needle length.
  • Needle attached or detachable, and the syringe tip type (luer lock or not).
  • Needle tip or bevel type, such as an intradermal bevel.
  • Safety-engineered feature, if any, and what the maker calls it.
  • Single-use status and FDA product code(s).

A manufacturer page may leave some of these out. The BD page, for instance, does not state sterility or graduations, so those need the instructions for use or the package label.

Safe use and handling basics

  • These are single-use devices. Do not reuse a syringe or needle; see do syringes expire for reading dates on packaging.
  • Follow the manufacturer’s instructions for use for the exact product, including how its safety feature is activated.
  • Dispose of used needles in a sharps container; see FDA-cleared sharps containers.
  • How to give or read a skin test is clinical practice and is outside this page; follow clinic protocols.

Common mistakes

  • Treating “tuberculin needle” as a standard size. It is a naming habit; gauge and length vary by product, as the table shows.
  • Assuming two products with the same name carry the same FDA coding or the same attached/detachable design.
  • Ordering from the name alone, without reading gauge, length, attachment and safety feature on the label or record.
  • Reusing a single-use device, or assuming a syringe size chart for insulin syringes applies to a tuberculin syringe.

For a related ordering checklist on another small syringe class, see bulk insulin syringes: what to verify before you order.

FAQ

What is a tuberculin needle?

It is the needle on a 1 mL tuberculin syringe, a small calibrated syringe with a fine, short needle. FDA classifies the parts as a piston syringe (21 CFR 880.5860) and a hypodermic single lumen needle (21 CFR 880.5570), both Class II.

What size is a tuberculin needle?

There is no single size. Labelled examples in the sources are 27 G x 3/8 in (BD) and 25 G x 5/8 in (two AccessGUDID records).

Is a 25 syringe the same as a tuberculin syringe?

Not necessarily. A 25 G needle can be on a tuberculin syringe, as in the two 25 G x 5/8 in records above, but gauge alone does not make a syringe a tuberculin syringe. Check fill volume and the product record.

Are tuberculin needles single use?

The records and manufacturer page cited here describe them as single-use disposable products. Check the instructions for use for your specific product.

Sources

  • openFDA device classification API, product codes FMF and FMI, https://api.fda.gov/device/classification.json, checked 1 November 2026.
  • 21 CFR 880.5860 (piston syringe) and 21 CFR 880.5570 (hypodermic single lumen needle), https://www.law.cornell.edu/cfr/text/21/880.5860 and https://www.law.cornell.edu/cfr/text/21/880.5570, checked 1 November 2026.
  • FDA AccessGUDID records 00850578007426, 00812460026878 and 05391530750219, https://accessgudid.nlm.nih.gov/devices/00850578007426, https://accessgudid.nlm.nih.gov/devices/00812460026878 and https://accessgudid.nlm.nih.gov/devices/05391530750219, checked 1 November 2026.
  • BD, product page 303327, 1 mL BD SafetyGlide Tuberculin Syringe with 27 G x 3/8 in. Permanently Attached Needle, https://www.bd.com/en-us/products-and-solutions/products/product-page.303327, checked 1 November 2026.

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