SEPARATION TECHNOLOGY, INC.

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Device Description : HemataChek is a three-level micro-hematocrit reference control for monitoring th HemataChek is a three-level micro-hematocrit reference control for monitoring the accuracy and presision of the HemataStat™Centrifuges and other methods used to measure whole blood spun hematacit values.

Device Class : 2

Duns Number: 195501127

Premarket Exempt : Yes

Product Code : GLK

Prescription Use : Yes

Device Count : 1

Device Description : HemataChek is a three-level micro-hematocrit reference control for monitoring th HemataChek is a three-level micro-hematocrit reference control for monitoring the accuracy and presision of the HemataStat™Centrifuges and other methods used to measure whole blood spun hematacit values.

Device Class : 2

Duns Number: 195501127

Premarket Exempt : Yes

Product Code : GLK

Prescription Use : Yes

Device Count : 1

Device Description : HemataChek is a three-level micro-hematocrit reference control for monitoring th HemataChek is a three-level micro-hematocrit reference control for monitoring the accuracy and presision of the HemataStat™Centrifuges and other methods used to measure whole blood spun hematacit values.

Device Class : 2

Duns Number: 195501127

Premarket Exempt : Yes

Product Code : GLK

Prescription Use : Yes

Device Count : 1

Device Class :

Duns Number: 195501127

Premarket Exempt : Yes

Product Code : GKG

Prescription Use : Yes

Device Count : 50

Device Class :

Duns Number: 195501127

Premarket Exempt : Yes

Product Code : GKG

Prescription Use : No

Device Count : 10

Device Class :

Duns Number: 195501127

Premarket Exempt : Yes

Product Code : GIO

Prescription Use : Yes

Device Count : 5

Device Class :

Duns Number: 195501127

Premarket Exempt : Yes

Product Code : GIO

Prescription Use : Yes

Device Count : 5

Device Class :

Duns Number: 195501127

Premarket Exempt : Yes

Product Code : GIO

Prescription Use : Yes

Device Count : 5

Device Class :

Duns Number: 195501127

Premarket Exempt : Yes

Product Code : GIO

Prescription Use : Yes

Device Count : 20

Device Description : UltraCrit Cleaning Tools are to be used to clean the UltraCrit and UltraCrit Plus devices.

Device Class :

Duns Number: 195501127

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 50