Hemagen Diagnostics, Inc.
Hemagen Diagnostics, Inc. holds FDA 510(k) medical device clearances, first cleared 1986, most recent 2004.
Top product codes for Hemagen Diagnostics, Inc.
Recent clearances by Hemagen Diagnostics, Inc.
- K041051 — RAICHEM BUN RATE REAGENT (LIQUID)
- K041052 — RAICHEM GLUCOSE UV (LIQUID)
- K041009 — RAICHEM CALCIUM (OCPC) LIQUID REAGENT
- K031101 — RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2
- K023784 — RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
- K022772 — RAICHEM LDL-CHOLESTEROL DIRECT REAGENT
- K022767 — RAICHEM LIPID CALIBRATOR
- K021194 — RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
- K022049 — MODIFICATION TO RAICHEM CALCIUM REAGENT
- K012649 — RAICHEM BUN RATE REAGENT
- K012668 — RAICHEM GLUCOSE UV REAGENT
- K012250 — RAICHEM MULTI-ANALYTE CALIBRATOR
- K010864 — ANALYST PANELS + ANALYTICAL TEST ROTOR
- K011126 — RAICHEM CREATININE URINE STANDARD
- K003012 — RAICHEM PHOSPORUS REAGENT
- K992224 — VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT
- K992241 — VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT
- K992243 — VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT
- K973822 — VIRGO ANCA SCREEN KIT
- K973823 — PR 3 ANTIBODY KIT
- K973824 — VIRGO PANCO KIT
- K972812 — RAICHEM PREALBUMIN SPIA
- K971909 — VIRGO AMA ELISA KIT
- K971039 — HEMAGEN ANTI CARDIOLIPIN SCREEN
- K944438 — HEMAGEN CMV IGG KIT
- K962276 — HEMAGEN ENA DSDNA KIT (EIA METHOD)
- K962836 — HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)
- K960324 — HEMAGEN CRP 150 KIT (EIA METHOD)
- K952076 — HEMAGEN ENA SCREENING KIT (EIA METHOD)
- K952077 — HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)
- K930272 — HEMAGEN CHAGAS' KIT (EIA METHOD)
- K950414 — HEMAGEN ENA SM/RMP KIT (EIA METHOD)
- K946120 — HEMAGEN ENA SS-B KIT (EIA METHOD)
- K946121 — HEMAGEN ENA SS-A KIT (EIA METHOD)
- K946122 — HEMAGEN ENA SCL-70 KIT (EIA METHOD)
- K946123 — HEMAGEN ENA SM KIT (EIA METHOD)
- K946124 — HEMAGEN ENA JO-1 KIT (EIA METHOD)
- K944288 — HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD)
- K941840 — HEMAGEN ACL IGA CALIBRATOR
- K935828 — HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)
- K932373 — HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0
- K915420 — HEMAGEN ENA [JO-1] KIT (EIA METHOD)
- K915272 — HEMAGEN ENA [RNP/SM] KIT (EIA METHOD)
- K915282 — HEMAGEN ENA SCL-70 KIT (EIA METHOD)
- K915058 — HEMAGEN ENA SCREENING KIT (EIA METHOD)
- K915234 — HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD)
- K910232 — HEMAGEN ENA SCREENING KIT
- K902139 — HEMAGEN ENA [JO-I] KIT
- K900617 — SERATEST ENA [SSA] KIT
- K894411 — SERATEST ENA [SCL-70] KIT
- K862700 — SERATEST ENA [SS-B] KIT
- K855221 — SERATEST RF (HEMAGGLUTINATION) KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.