INVIVOSCRIBE, INC.

Address:10222 Barnes Canyon Road, Building 1,San Diego,CA,92121,US

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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

Reagents, Specific, Analyte (MVU) (10)

Premarket Exempt

Yes No

Clear

Invivoscribe - 00810022731246 Catalog Number : A4120449

Device Description : This analyte specific reagent targets the ITD analyte within the human FLT3 gene.

Device Class : 1

Duns Number: 836976779

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Invivoscribe - 00810022731253 Catalog Number : A4120459

Device Description : This analyte specific reagent targets the ITD analyte within the human FLT3 gene.

Device Class : 1

Duns Number: 836976779

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Invivoscribe - 00810022731260 Catalog Number : A4120469

Device Description : This analyte specific reagent targets the ITD analyte within the human FLT3 gene.

Device Class : 1

Duns Number: 836976779

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Invivoscribe - 00810022731277 Catalog Number : A4120479

Device Description : This analyte specific reagent targets the ITD analyte within the human FLT3 gene.

Device Class : 1

Duns Number: 836976779

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Invivoscribe - 00810022731284 Catalog Number : A4160001

Device Description : This analyte specific reagent targets the NPM1 gene in Exon 12

Device Class : 1

Duns Number: 836976779

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Invivoscribe - 00810022731536 Catalog Number : A1010010

Device Description : Analyte Specific Reagent that targets the framework 1 region of the human immuno Analyte Specific Reagent that targets the framework 1 region of the human immunoglobulin heavy chain gene.

Device Class : 1

Duns Number: 836976779

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Invivoscribe - 00810022731543 Catalog Number : A1010011

Device Description : Analyte specific reagent that targets the framework 1 region of the human immuno Analyte specific reagent that targets the framework 1 region of the human immunoglobulin heavy chain gene.

Device Class : 1

Duns Number: 836976779

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Invivoscribe - 00810022731550 Catalog Number : A1010020

Device Description : Analyte Specific Reagent that targets the framework 2 region of the human immuno Analyte Specific Reagent that targets the framework 2 region of the human immunoglobulin heavy chain gene.

Device Class : 1

Duns Number: 836976779

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Invivoscribe - 00810022731567 Catalog Number : A1010030

Device Description : Analyte specific reagent that targets the framework 3 region of the human immuno Analyte specific reagent that targets the framework 3 region of the human immunoglobulin heavy chain gene.

Device Class : 1

Duns Number: 836976779

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

Invivoscribe - 00810022731574 Catalog Number : A1010031

Device Class : 1

Duns Number: 836976779

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

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