UrineTime II™ 24 Hour Urine Collection System
UrineTime™II includes all you need to collect 2 separate samples from a patient concurrently over a 24 hour period. Everything is included even disposal bags. UrineTime™ II from Labcon improves on an already great product, the P-Splitter™. The 2 liter keyed bottles are much more stable than earlier models and with their keyed sides they now stay firmly oriented and locked together.
UrineTime™II Solves an old problem, this problem occurs when more than one assay is needed for a single 24 hour urine sample and the assays require different preparations or preservatives.
Unlike the usual method of collecting samples over two days UrineTime™ II reduces the time it takes to collect samples and speeds the diagnosis and treatment process.
UrineTime™ II is convenient and easy for patients to understand. And since treatment can begin a full day earlier better care is assured with UrineTime™ II.
UrineTime™ II is a 24 hour urine proportioning system. The collected urine sample is poured into the attached funnel on the top of the system and then automatically split into two equal portions. This gives you 2 samples in the time it takes to general one.
UrineTime™ II is provided with everything needed to collect two 24 hour samples simultaneously. Staff time and labor is reduced since labels, packaging and transport accessories are provided in a neat package. And UrineTime™ II is perfect for outpatient use so there is no need to ensure compliance through admission.
Available in a single use kit, 4 kits in a box, or an economical ready to assemble bulk package.
|Endotoxin Free (Non pyrogenic)
Product samples are exposed to endotoxin-free water and the resulting extraction fluid is tested for contamination using the kinetic turbidimetric Limulus Amoebocyte Lysate (LAL) assay protocol and USP guidelines. All products tested must display less than 0.05 EU/ml to be certified free of endotoxin.
|Nuclease Free (RNase/DNase)
Product samples are exposed to nuclease-free water and the resulting extraction fluid is tested for nuclease activity on commercially available 7.5 kb Poly(A) tailed RNA (1µg) and HindIII-digested DNA (1µg) with a one hour 37°C incubation in appropriate buffers. Results are visualized on an agarose gel with appropriate positive and negative controls. Extraction fluid samples must show no degradation of the nucleic acids by the extraction fluid has occurred for the product to be certified as RNase-free and DNase-free
|Adenosine Triphosphate (ATP)
Product sample surfaces are tested for the presence of adenosine triphosphate (ATP) using a controlled bioluminescence reaction to detect contamination. Luminescence data is compared to results generated by ATP-free surfaces and surfaces with known amounts of ATP as a positive control. The relative light units result must indicate less than 2 X 10-12 mg/µl of ATP for the product to be certified as ATP free.
|Bovine Spongiform Encephalopathy-Transmissible Spongiform Encephalopathy
These products contain resins that are processed under conditions proven to exceed the European Union standard as listed in the 22nd Commission Directive EC 98/16/EC of March 5th, 1998 as annexed to council Directive EC 76/768/EEC and further Amendment 419 Annex II of 12 June 2001.
|Medical Grade (USP)
U.S Pharmacoepia Methods and Guidelines (U.S.P Class VI) are used if applicable. We only use medical grade resins and pre-test all resins for contaminants prior to use. Resins are compliant with FDA CFR title 21-177.1520, 178.3295, 178.3297.
|California Prop 65
No Labcon manufactured disposables contain any of the “listed chemicals” as referenced in the California Safe Drinking Water and Toxic Enforcement Act of 1986, (Prop 65) as revised May 25, 2018.
|Phthalates & Oleamide
All our resins are medical grade and are certified free of Bisphenol A (BPA), Oleamide, DiHEMDA, and Phthalates.
|Substances of Very High Concern & REACH
All Labcon products are compliant with RoHS Directive 2002/95/EC/-2011/65-2015/863, are free of Substances of Very High Concern (SVHC), and are EU REACH Regulation (EC) No 1907/2006 compliant.
These products are Made in USA and all components meet the requirements for US origin under the NAFTA agreement.
|U.S. FDA Registered
Labcon is a U.S. FDA registered medical device manufacturer. Our facility is registered by the U.S. government to comply with CFR21 GMP regulations for manufacturing medical devices.
As applicable Labcon products meet the requirements for CE marking under regulation 2017/746.
|ISO 9001 Quality Registration
Labcon has been registered to the ISO 9001 quality management system standar since 1997 and maintains registration to ISO 9001:2015.
|USP Class VI
|Amber and White