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

Calibrator, Secondary (JIT) (6) Multi-Analyte Controls Unassayed (OHQ) (4)

Premarket Exempt

Yes

Clear

Exact Diagnostics - 00812242030512 Catalog Number : CTNGRC

Device Description : CT/NG Run Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030529 Catalog Number : JCVP100

Device Description : JCV Verification Panel

Device Class : 2

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030536 Catalog Number : JCVL101

Device Description : JCV Low Run Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030543 Catalog Number : JCVH102

Device Description : JCV High Run Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030550 Catalog Number : HIVP200

Device Description : HIV-1 Verification Panel 1.4mL

Device Class : 2

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030567 Catalog Number : HIVL201

Device Description : HIV-1 1E3 cp/mL Precision

Device Class : 2

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030574 Catalog Number : HIVH202

Device Description : HIV-1 1E5 cp/mL Precision

Device Class : 2

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030581 Catalog Number : HIVLOD

Device Description : HIV-1 LOD

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030598 Catalog Number : CMVP200

Device Description : CMV Verification Panel 1.4mL

Device Class : 2

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030604 Catalog Number : CMVL201

Device Description : CMV 1E3 IU/mL Precision

Device Class : 2

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : No

Device Count : 1

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