EXACT DIAGNOSTICS, LLC

Address:100 South Jones Street Suite #100,Fort Worth,TX,76104,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Multi-Analyte Controls Unassayed (OHQ) (10)

Premarket Exempt

Yes

Clear

Exact Diagnostics - 00812242030710 Catalog Number : HSVP200

Device Description : HSV Verification Panel

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030727 Catalog Number : MRSAP200

Device Description : MRSA Verification Panel

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030734 Catalog Number : CDFP200

Device Description : C. difficile Verification Panel

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030741 Catalog Number : CTNGP200

Device Description : CT/NG Verification Panel

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030758 Catalog Number : RPRC

Device Description : Respiratory Run Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030765 Catalog Number : ANARC

Device Description : Anaplasma Run Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030772 Catalog Number : BABRC

Device Description : Babesia Run Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030789 Catalog Number : BRTRC

Device Description : Bartonella Run Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030796 Catalog Number : BORRC

Device Description : Borrelia Run Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030802 Catalog Number : ERLRC

Device Description : Ehrlichia Run Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

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