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 - 00812242030208 Catalog Number : HIVAMR

Device Description : HIV-1 Analytical Measurement Range Panel

Device Class : 2

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030215 Catalog Number : HCVAMR

Device Description : HCV Analytical Measurement Range Panel

Device Class : 2

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030222 Catalog Number : HBVAMR

Device Description : HBV Analytical Measurement Range Panel

Device Class : 2

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030239 Catalog Number : HPV16C

Device Description : HPV Genotype 16 Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030246 Catalog Number : HPV18C

Device Description : HPV Genotype 18 Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030253 Catalog Number : HPV68C

Device Description : HPV Genotype 68 Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030260 Catalog Number : HPVNEG

Device Description : HPV Negative Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030284 Catalog Number : ZKVP100

Device Description : Zika Verification Panel

Device Class : 2

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030291 Catalog Number : ZKVL101

Device Description : Zika Low Run Control

Device Class : 1

Duns Number: 079898166

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Exact Diagnostics - 00812242030307 Catalog Number : ZKVH102

Device Description : Zika 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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