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 AMHCE, FDA
CE, FDA
CE, FDA
CE, FDA
CE, FDA
CE, FDA
CE
CE, FDA
CE, FDA
CE, FDA
CE
CE
CEPrenatal Supervision Certification HYE-5359 Beta hCG
HYE-5337 AFP
HYE-5351 Free EstriolCE
CE
CE, FDAEndocrinology – Thyroid Function Certification HYE-5356 T3, free
HYE-5357 T4, free
HYE-5385 TSH
HYE-5697 T3 (under design change)
HYE-5698 T4CE
CE
CE
CE
CEGastroenterology – 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 ElastaseCE
CE
CE
CE
CE
CEDiabetes Certification HYC-5325 HbA1c
HYE-5361 InsulinCE
CE, FDACardiac Markers Certification HYC-5321 D-dimer
HYC-5613 CRP-HSCE
CECardiac 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 USAHypertension Certification HYE-5338 Aldosterone
HYE-5373 Renin (active)CE
CEOncology & Tumor markers Certification HYE-5337 AFP
HYE-5359 Beta hCG
HYE-5370 PSA
HYE-5371 Free PSA (pending on certification)
HYE-5382 TM-CA 72-4CE
CE
CE
CE
CEBone Metabolism Certification HYE-5334 25-OH Vitamin D (total) CE Gastrointestinal Disease Certification HYC-5319 CRP
HYE-5767 Calprotectin
HYE-6123 Pancreatic ElastaseCE
CE
CENephrology & Renal Function Certification HYC-5320 Cystatin C
HYE-5343 Cortisol
HYE-5347 DHEA-S
HYE-5769 Hepcidin 25 (bioactive)CE
CE
CE, FDA
CEIron Metabolism & Anemia Certification HYE-5769 Hepcidin 25 (bioactive)
HYC-5319 CRPCE
CESaliva Diagnostic Certification HYE-5344 Salivary Cortisol CE