GREAT LAKES DIAGNOSTICS, INC.

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Device Class : 2

Duns Number: 804870996

Premarket Exempt : No

Product Code : GHM

Prescription Use : No

Device Count : 1

- Catalog Number : GLD-250

Device Description : A qualitative solubility test kit used to detect the presence of sickling hemogl A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human blood or sickle cell control material. Contains 250 tests

Device Class : 2

Duns Number: 804870996

Premarket Exempt : No

Product Code : GHM

Prescription Use : No

Device Count : 1

- Catalog Number : GLD-1

Device Description : A positive and negative lyophilized whole blood control to test for the presence A positive and negative lyophilized whole blood control to test for the presence of Hemoglobin S in solubility tests. Contains 2 Positive control vials and 2 Negative control vials.

Device Class : 2

Duns Number: 804870996

Premarket Exempt : No

Product Code : GHM

Prescription Use : No

Device Count : 1

- Catalog Number : GLD-20

Device Description : A qualitative solubility test kit used to detect the presence of sickling hemogl A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human blood or sickle cell control material. Contains 20 tests.

Device Class : 2

Duns Number: 804870996

Premarket Exempt : No

Product Code : GHM

Prescription Use : No

Device Count : 1

Device Description : A qualitative solubility test kit used to detect the presence of sickling hemogl A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human blood or sickle cell control material. Contains 12 tests.

Device Class : 2

Duns Number: 804870996

Premarket Exempt : No

Product Code : GHM

Prescription Use : No

Device Count : 1