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) (6) Calibrator, Secondary (JIT) (4)

Premarket Exempt

Yes

Clear

Exact Diagnostics - 00812242030314 Catalog Number : ADVP100

Device Description : Adenovirus Verification Panel

Device Class : 2

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030321 Catalog Number : ADVL101

Device Description : Adenovirus Low Run Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030338 Catalog Number : ADVH102

Device Description : Adenovirus High Run Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030345 Catalog Number : VZVP100

Device Description : VZV Verification Panel

Device Class : 2

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030352 Catalog Number : VZVL101

Device Description : VZV Low Run Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030369 Catalog Number : VZVH102

Device Description : VZV High Run Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030376 Catalog Number : HV6AP100

Device Description : HHV-6A Verification Panel

Device Class : 2

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030383 Catalog Number : HV6BP100

Device Description : HHV-6B Verification Panel

Device Class : 2

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030390 Catalog Number : HV6L101

Device Description : HHV-6 Low Run Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030406 Catalog Number : HV6H102

Device Description : HHV-6 High Run Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

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