Invivoscribe

GUDID 00810022730362

Analyte specific reagent that targets the variable and the joining regions within the human immunoglobulin lambda light chain locus.

INVIVOSCRIBE, INC.

Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD

• Primary Device ID: 00810022730362
• NIH Device Record Key: 475b34fa-bfa8-47da-a487-bd207ac12741
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invivoscribe
• Version Model Number: A1030011
• Company DUNS: 836976779
• Company Name: INVIVOSCRIBE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810022730362 [Primary]

FDA Product Code

• MVU: Reagents, Specific, Analyte

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-29
• Device Publish Date: 2020-10-21

On-Brand Devices [Invivoscribe]

• 00810022731598: Analyte specific reagent targets the diversity and joining regions of the human immunoglobulin h
• 00810022731574: Analyte specific reagent that targets the framework 3 region of the human immunoglobulin heavy c
• 00810022731567: Analyte specific reagent that targets the framework 3 region of the human immunoglobulin heavy c
• 00810022731550: Analyte Specific Reagent that targets the framework 2 region of the human immunoglobulin heavy c
• 00810022731543: Analyte specific reagent that targets the framework 1 region of the human immunoglobulin heavy c
• 00810022731536: Analyte Specific Reagent that targets the framework 1 region of the human immunoglobulin heavy c
• 00810022730171: Analyte specific reagent that targets the framework 2 region of the human immunoglobulin heavy c
• 00810022730157: Analyte specific reagent that targets the framework 3 region of the human immunoglobulin heavy c
• 00810022730140: Analyte specific reagent that targets the framework 3 region of the human immunoglobulin heavy c
• 00810022730126: Analyte specific reagent that targets the framework 2 region of the human immunoglobulin heavy c
• 00810022730119: Analyte specific reagent that targets the framework 1 region of the human immunoglobulin heavy c
• 00810022730096: Analyte specific reagent that targets the diversity and joining regions of the human immunoglobu
• 00810022730386: Analyte specific reagent that targets the variable and the joining regions within the human T ce
• 00810022730379: Analyte specific reagent that targets the variable and the joining regions within the human T ce
• 00810022730362: Analyte specific reagent that targets the variable and the joining regions within the human immu
• 00810022730348: Analyte specific reagent targets the variable, the Kde, and the intragenic regions within the hu
• 00810022730331: Analyte specific reagent that targets the variable, the Kde, and the intragenic regions within t
• 00810022730324: Analyte specific reagent that targets the variable and the joining regions within the human immu
• 00810022730317: Analyte specific reagent that targets the variable and the joining regions within the human immu
• 00810022730195: Analyte specific reagent that targets the framework 2 region of the human immunoglobulin heavy c
• 00810022730393: This product targets the variable and the joining regions within the human T cell receptor beta
• 00810022730423: This product targets the joining and the diversity regions within the human T cell receptor beta
• 00810022730416: This product targets the joining and the diversity regions within the human T cell receptor beta
• 00810022730409: This product targets the variable and the joining regions within the human T cell receptor beta
• 00810022730683: This product targets the human BCR/ABL fusion gene.
• 00810022730676: This product targets the human BCR/ABL fusion gene.
• 00810022730669: This product targets the human BCR/ABL fusion gene.
• 00810022730652: This product targets the human BCR/ABL fusion gene.
• 00810022730645: This product targets the human BCR/ABL fusion gene.
• 00810022730638: This product targets the human BCR/ABL fusion gene.
• 00810022730621: This product targets the human BCR/ABL fusion gene.
• 00810022730614: This product targets the human BCL2/JH fusion gene.
• 00810022730607: This product targets the human BCL2/JH fusion gene.
• 00810022730591: This product targets the human BCL2/JH fusion gene.
• 00810022730546: This product targets the variable and the joining regions within the human T cell receptor gamma
• 00810022730522: This product targets the variable and the joining regions within the human T cell receptor gamma
• 00810022730515: This product targets the variable and the joining regions within the human T cell receptor gamma
• 00810022730508: This product targets the variable and the joining regions within the human T cell receptor gamma
• 00810022730492: This product targets the variable and the joining regions within the human T cell receptor gamma
• 00810022730485: This product targets the variable and the joining regions within the human T cell receptor gamma
• 00810022730461: This product targets the variable and the joining regions within the human T cell receptor gamma
• 00810022730430: This product targets the variable, the diversity, and the joining regions within the human T cel
• 00810022731277: This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
• 00810022731260: This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
• 00810022731253: This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
• 00810022731246: This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
• 00810022731239: This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
• 00810022731222: This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
• 00810022731215: This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
• 00810022731208: This analyte specific reagent targets the ITD analyte within the human FLT3 gene.