ELITECHGROUP INC.

Address:370 West 1700 South,LOGAN,UT,84321,US

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Device Description : Accu-Sed Plus ESR Controls are whole blood reference control materials designed Accu-Sed Plus ESR Controls are whole blood reference control materials designed to monitor patient erythrocyte sedimentation rate (ESR) procedures. Accu-Sed Plus Normal / Abnormal ESR Controls help to monitor technique as well as environmental, physical and mechanical factors such as room temperature, tube position, and vibration.

Device Class : 1

Duns Number: 052423787

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

Device Description : Accu-Sed Plus ESR Controls are whole blood reference control materials designed Accu-Sed Plus ESR Controls are whole blood reference control materials designed to monitor patient erythrocyte sedimentation rate (ESR) procedures. Accu-Sed Plus Normal / Abnormal ESR Controls help to monitor technique as well as environmental, physical and mechanical factors such as room temperature, tube position, and vibration.

Device Class : 1

Duns Number: 052423787

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

Device Description : Accu-Sed Plus ESR Controls are whole blood reference control materials designed Accu-Sed Plus ESR Controls are whole blood reference control materials designed to monitor patient erythrocyte sedimentation rate (ESR) procedures. Accu-Sed Plus Normal / Abnormal ESR Controls help to monitor technique as well as environmental, physical and mechanical factors such as room temperature, tube position, and vibration.

Device Class : 1

Duns Number: 052423787

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

Device Description : The Macroduct System is intended for clinical laboratory use by qualified person The Macroduct System is intended for clinical laboratory use by qualified personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis.

Device Class : 2

Duns Number: 052423787

Premarket Exempt : No

Product Code : KTB

Prescription Use : Yes

Device Count : 1

Device Description : ELITechGroup Sweat Controls for Cystic Fibrosis Testing are assayed controls int ELITechGroup Sweat Controls for Cystic Fibrosis Testing are assayed controls intended as a means of validating the measurement of conductivity , osmolality, or chloride in patient samples.

Device Class : 1

Duns Number: 052423787

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

Device Description : For use with Macroduct® Advanced Sweat Collection System to induce sweat for dia For use with Macroduct® Advanced Sweat Collection System to induce sweat for diagnosis of Cystic Fibrosis.

Device Class : 2

Duns Number: 052423787

Premarket Exempt : No

Product Code : KTB

Prescription Use : No

Device Count : 1

Device Description : For use with Macroduct® Advanced Sweat Collection System to induce sweat for dia For use with Macroduct® Advanced Sweat Collection System to induce sweat for diagnosis of Cystic Fibrosis

Device Class : 2

Duns Number: 052423787

Premarket Exempt : No

Product Code : KTB

Prescription Use : No

Device Count : 1

- Catalog Number : EX-10610

Device Description : Automated Erythrocyte Sedimentation Rate (ESR) Analyzer

Device Class : 1

Duns Number: 052423787

Premarket Exempt : Yes

Product Code : GKB

Prescription Use : No

Device Count : 1

- Catalog Number : EX-10318

Device Description : Automated Erythrocyte Sedimentation Rate (ESR) Analyzer

Device Class : 1

Duns Number: 052423787

Premarket Exempt : Yes

Product Code : GKB

Prescription Use : No

Device Count : 1

- Catalog Number : EX-10618

Device Description : Automated Erythrocyte Sedimentation Rate (ESR) Analyzer

Device Class : 1

Duns Number: 052423787

Premarket Exempt : Yes

Product Code : GKB

Prescription Use : No

Device Count : 1