EXACT DIAGNOSTICS, LLC

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) (7) Calibrator, Secondary (JIT) (3)

Premarket Exempt

Yes

Clear

Exact Diagnostics - 00812242030000 Catalog Number : HIVP100

Device Description : HIV-1 Verification Panel

Device Class : 2

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030017 Catalog Number : HIVL101

Device Description : HIV-1 Low Run Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030024 Catalog Number : HIVH102

Device Description : HIV-1 High Run Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030031 Catalog Number : CMVP100

Device Description : CMV Verification Panel

Device Class : 2

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030048 Catalog Number : CMVL101

Device Description : CMV Low Run Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030055 Catalog Number : CMVH102

Device Description : CMV High Run Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030062 Catalog Number : NEG000

Device Description : Negative Run Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030079 Catalog Number : NEG050

Device Description : Bulk Negative

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030086 Catalog Number : HCVP100

Device Description : HCV Verification Panel

Device Class : 2

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030093 Catalog Number : HCVL101

Device Description : HCV Low Run Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

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