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aters ERA

About Waters ERA

Laboratories partner with Waters ERA because, regardless of the internal QA or regulatory compliance challenges they face, we have the programs in place to validate and document the quality of the data they produce.

Founded in 1977, ERA has evolved to become the premier providers of Proficiency Testing (PT) products and Certified Reference Materials (CRMs) to thousands of laboratories around the world and across multiple industries. With the financial strength of our parent company, Waters Corporation, we continue to expand our capabilities and worldwide presence by now serving laboratories in more than 80 countries.

Our in-depth knowledge of major international accreditation and regulatory bodies enables us to expertly guide customers through the analytical challenges they face. Whether you are a commercial, research or government laboratory, small business or a multi-national corporation, you can count on Waters ERA’s experience, products and services to simplify compliance and ensure quality.

HYBRID XL: Now FDA exempt for Class I

HYBRID XL: Now FDA exempt for Class I

Using innovative and unique technology the DRG HYBRiD-XL® allows, for the first time, the simultaneous measurement of immunoassays and clinical chemistry parameters, including turbidimetric tests in one sample.

Up to 40 tests of different types or 40 times of the same test, or up to 40-patient samples can be ordered by the medical practitioner over a wide range of pre-packaged tests to serve different specialties.

  • Available Assays - June 2020

    Regular – Immunoassay (Special ELISA)
    Underlined – Clinical Chemistry (Immunoturbidimetry)

     

    Endocrinology – Gynecology Certification
    HYE-5333 17-OH Progesterone
    HYE-5339 Androstenedione
    HYE-5346 DHEA
    HYE-5347 DHEA-S
    HYE-5349 Estradiol
    HYE-5355 FSH
    HYE-5359 Beta hCG
    HYE-5362 LH
    HYE-5368 Progesterone
    HYE-5369 Prolactin
    HYE-5376 Testosterone
    HYE-5378 Free Testosterone
    HYE-5770 AMH
    CE, FDA
    CE, FDA
    CE, FDA
    CE, FDA
    CE, FDA
    CE, FDA
    CE
    CE, FDA
    CE, FDA
    CE, FDA
    CE
    CE
    CE
    Prenatal Supervision Certification
    HYE-5359 Beta hCG
    HYE-5337 AFP
    HYE-5351 Free Estriol
    CE
    CE
    CE, FDA
    Endocrinology – Thyroid Function Certification
    HYE-5356 T3, free
    HYE-5357 T4, free
    HYE-5385 TSH
    HYE-5697 T3 (under design change)
    HYE-5698 T4
    CE
    CE
    CE
    CE
    CE
    Gastroenterology – Celiac Disease Certification
    HYE-5767 Calprotectin
    HYE-5819 Anti-DGP IgA
    HYE-5820 Anti-DGP IgG
    HYE-5894 Anti-tTG IgA
    HYE-5895 Anti-tTG IgG
    HYE-6123 Pancreatic Elastase
    CE
    CE
    CE
    CE
    CE
    CE
    Diabetes Certification
    HYC-5325 HbA1c
    HYE-5361 Insulin
    CE
    CE, FDA
    Cardiac Markers Certification
    HYC-5321 D-dimer
    HYC-5613 CRP-HS
    CE
    CE
    Cardiac Acute Phase Certification
    HYC-5613 CRP-HS CE

     

    FDA – Product is FDA Class I 510(k) exempt
    CE (without FDA) – product is RUO in the USA

     

    Hypertension Certification
    HYE-5338 Aldosterone
    HYE-5373 Renin (active)
    CE
    CE
    Oncology & Tumor markers Certification
    HYE-5337 AFP
    HYE-5359 Beta hCG
    HYE-5370 PSA
    HYE-5371 Free PSA (pending on certification)
    HYE-5382 TM-CA 72-4
    CE
    CE
    CE
    CE
    CE
    Bone Metabolism Certification
    HYE-5334 25-OH Vitamin D (total) CE
    Gastrointestinal Disease Certification
    HYC-5319 CRP
    HYE-5767 Calprotectin
    HYE-6123 Pancreatic Elastase
    CE
    CE
    CE
    Nephrology & Renal Function Certification
    HYC-5320 Cystatin C
    HYE-5343 Cortisol
    HYE-5347 DHEA-S
    HYE-5769 Hepcidin 25 (bioactive)
    CE
    CE
    CE, FDA
    CE
    Iron Metabolism & Anemia Certification
    HYE-5769 Hepcidin 25 (bioactive)
    HYC-5319 CRP
    CE
    CE
    Saliva Diagnostic Certification
    HYE-5344 Salivary Cortisol CE

To enquire about this product, please use the contact form found here

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