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Quick guide - hemaPEN

Part number: MN-1238-G

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hemaPEN®

Download: Quick guide - hemaPEN [PDF]

Also see: Quick guide translations - hemaPEN

Also see: Instructions for use - hemaPEN

Also see: Video - Instructional video for hemaPEN use

hemaPEN® is supplied for therapeutic or IVD use in Australia, New Zealand, UK, EU and USA only: ARTG number: 280007; CE mark, general IVD; US FDA number: D410490. Outside of the territories listed above, the hemaPEN is supplied for research purposes only and not for therapeutic or diagnostic use.

Collections: All, hemaPEN, hemaPEN (all), Instructions for use, Literature - All, Literature - Health, Microsampling, Sampling, Support Items

Category: ARTG, ARTG 280007, Australia, Australian Register of Therapeutic Goods, Blood, CE mark, Class I, Clinical, DBS, EU, FDA, Health, hemaPEN, Histology, IFU, IVD, Life, MHRA 64872, Microsampling, New Zealand, Pathology, Research, Sample collection, Sampling, Support, TGA, Therapeutic Goods Administration, UK, US FDA, US FDA D410490, USA

Type: Instructions for use


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hemaPEN

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Advanced precision microsampling

hemaPEN provides a convenient sampling procedure for collection and storage of four dried blood spot (DBS) samples to drive information-rich decision making.

Unlike conventional DBS sampling tools, hemaPEN enables collection of an accurate and precise fixed micro-volume, and is designed to maintain sample integrity for quantitative analysis.

An easy-to-use sophisticated microsampling tool in the hands of non-analysts.

Features and benefits

  • Pen-like design for intuitive use.
  • Ability to collect blood from any source.
  • Capillary-based technology enables autonomous accurate fixed volume collection.
  • Four replicate samples from a single source.
  • Eliminates analytically relevant hematocrit bias.
  • Single-use and tamper-resistant.
  • Contained sample to minimize contamination.
  • Consistent sample drying profile.
  • Dried format for simplified storage and logistics.
  • Samples integrated directly into analytical workflow.
  • Sample cartridge compatible with standard 96-/24-well plates.
  • 2D barcode and individual device serial number for traceability and chain of custody.
  • Space available for customized laboratory labelling.

Recommended applications

  • Quantitative analysis
  • Small volume sampling
  • Frequent sampling
  • Remote sampling
  • Blood sampling

Product specifications

hemaPEN functionality remains consistent independent of substrate. Each hemaPEN is identified through a specific model number which references substrate material, volume of capillaries and hemaPEN model type.

Substrate Volume reference Model Model number
D* = 226™ 300 = 2.74 μL S = Standard (base model) D300S
W† = 903® 300 = 2.74 μL S = Standard (base model) W300S

Technical data

Product features
Sample type Whole blood
Storage format Dried
Sample volumetric accuracy 2.74 μL ±5% (0.14 μL)
Volumetric precision CV <2.5% (interdevice)
Number of samples collected 4
Capillary specification K2 EDTA-coated borosilicate Type 1 USP
Substrate dimensions 3.5 mm diameter
Substrate 226™ or 903®
Shelf life One year
Material and colors
Product color White main body, a clear plastic tip and base and a green indicator stripe
Packaging
Units/pack Provided as a single unit per pack
Pack dimensions 160 mm x 230 mm x 50 mm

*226™ supplied by PerkinElmer Pty Ltd. 226™ is a trademark of PerkinElmer, Inc or its affiliated entities. †903® 100% cotton fiber supplied by Eastern Business Forms, Inc. 903® is a registered trademark of Eastern Business Forms, Inc.

More

More information about hemaPEN

hemaPEN® is supplied for therapeutic or IVD use in Australia, New Zealand, UK, EU and USA only: ARTG number: 280007; CE mark, general IVD; US FDA number: D410490. Outside of the territories listed above, the hemaPEN is supplied for research purposes only and not for therapeutic or diagnostic use.

View full product details
 

Brochure - hemaPEN

hemaPEN®

Download: Brochure - hemaPEN [PDF]

hemaPEN® is supplied for therapeutic or IVD use in Australia, New Zealand, UK, EU and USA only: ARTG number: 280007; CE mark, general IVD; US FDA number: D410490. Outside of the territories listed above, the hemaPEN is supplied for research purposes only and not for therapeutic or diagnostic use.

View full product details
 

Product Specification Sheet - hemaPEN

hemaPEN®

Download: Product Specification Sheet - hemaPEN [PDF]

hemaPEN® is supplied for therapeutic or IVD use in Australia, New Zealand, UK, EU and USA only: ARTG number: 280007; CE mark, general IVD; US FDA number: D410490. Outside of the territories listed above, the hemaPEN is supplied for research purposes only and not for therapeutic or diagnostic use.

View full product details
 

Quick guide translations - hemaPEN

hemaPEN®

Download: Quick guide translations - hemaPEN [PDF]

Languages:

  • Bulgarian/български (BG)
  • Croatian/Hrvatski (HR)
  • Czech/čeština (CS)
  • Danish/Dansk (DA)
  • Dutch/Nederlands (NL)
  • Estonian/Eesti keel (ET)
  • French/Français (FR)
  • German/Deutsch (DE)
  • Greek/Ελληνικά (EL)
  • Hungarian/Magyar (HU)
  • Italian/Italiano (IT)
  • Latvian/Latviešu valoda (LV)
  • Lithuanian/Lietuvių kalba (LT)
  • Norwegian/Norsk (NO)
  • Polish/Polski (PL)
  • Portuguese/Português (PT)
  • Romanian/Română (RO)
  • Slovak/Slovenčina (SK)
  • Slovene/Slovenščina (SL)
  • Spanish/Español (ES)
  • Swedish/Svenska (SV)

Also see: Quick guide - hemaPEN

Also see: Instructions for use - hemaPEN

Also see: Video - Instructional video for hemaPEN use

hemaPEN® is supplied for therapeutic or IVD use in Australia, New Zealand, UK, EU and USA only: ARTG number: 280007; CE mark, general IVD; US FDA number: D410490. Outside of the territories listed above, the hemaPEN is supplied for research purposes only and not for therapeutic or diagnostic use.

View full product details