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For in vitro diagnostic use. Others cobas HbA1c Test Gen. 2 IVD cobas® HbA1c Test Gen. 2 PID00000980 09 200 509 190 9 200 509 190 09200509190 9200509190 09200509190 cobas click HbA1c Test 20 PC Gen. 2 cobas HbA1c Test Gen. 2 07613336218006 Reagents, kits 20 tests cobas b 101, cobas click true 09626123001 cobas HbA1c Test Gen. 2 cobas HbA1c Test Gen. 2 en 1 FF0000000717BB0E FF0000000717BB0E 09200509190 7075 cobas b 101 10395 cobas click Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative. Intended use
The cobas HbA1c Test Gen. 2 assay is an in vitro diagnostic test designed to quantitatively determine the % hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human capillary and K2/K3‑EDTA‑anticoagulated venous whole blood by photometric transmission measurement. An estimated average glucose level (eAG) is calculated. HbA1c determinations are useful for monitoring of long‑term blood glucose control in individuals with diabetes mellitus. Moreover, this test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients with prediabetes, who are at risk for developing diabetes. The cobas HbA1c Test Gen. 2 assay is intended for near‑patient testing. The cobas HbA1c Test Gen. 2 assay is intended to be used with the cobas b 101 instrument and with the cobas click instrument. en