Exact Diagnostics HSV2P100

GUDID 00812242030444

HSV-2 Verification Panel

EXACT DIAGNOSTICS, LLC

Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, calibrator

• Primary Device ID: 00812242030444
• NIH Device Record Key: 5096b98c-59d2-4668-88d9-7932a64d7065
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exact Diagnostics
• Version Model Number: HSV2P100
• Catalog Number: HSV2P100
• Company DUNS: 079898166
• Company Name: EXACT DIAGNOSTICS, LLC
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8179899262
• Email: customerservice@exactdiagnostics.com
• Phone: 8179899262
• Email: customerservice@exactdiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812242030444 [Primary]

FDA Product Code

• JIT: Calibrator, Secondary

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: 2018-10-25
• Device Publish Date: 2018-09-24

On-Brand Devices [Exact Diagnostics]

• 00812242030703: HBV LOD
• 00812242030697: HBV 1E6 IU/mL Precision
• 00812242030680: HBV 1E3 IU/mL Precision
• 00812242030673: HBV Verification Panel 1.4mL
• 00812242030666: HCV LOD
• 00812242030659: HCV 1E6 IU/mL Precision
• 00812242030642: HCV 1E3 IU/mL Precision
• 00812242030635: HCV Verification Panel 1.4mL
• 00812242030628: CMV LOD
• 00812242030611: CMV 5E5 IU/mL Precision
• 00812242030604: CMV 1E3 IU/mL Precision
• 00812242030598: CMV Verification Panel 1.4mL
• 00812242030581: HIV-1 LOD
• 00812242030574: HIV-1 1E5 cp/mL Precision
• 00812242030567: HIV-1 1E3 cp/mL Precision
• 00812242030550: HIV-1 Verification Panel 1.4mL
• 00812242030543: JCV High Run Control
• 00812242030536: JCV Low Run Control
• 00812242030529: JCV Verification Panel
• 00812242030512: CT/NG Run Control
• 00812242030505: Enterovirus Run Control
• 00812242030499: Parvovirus B19 High Run Control
• 00812242030482: Parvovirus B19 Low Run Control
• 00812242030475: Parvovirus B19 Verification Panel
• 00812242030468: HSV-2 High Run Control
• 00812242030451: HSV-2 Low Run Control
• 00812242030444: HSV-2 Verification Panel
• 00812242030437: HSV-1 High Run Control
• 00812242030420: HSV-1 Low Run Control
• 00812242030413: HSV-1 Verification Panel
• 00812242030406: HHV-6 High Run Control
• 00812242030390: HHV-6 Low Run Control
• 00812242030383: HHV-6B Verification Panel
• 00812242030376: HHV-6A Verification Panel
• 00812242030369: VZV High Run Control
• 00812242030352: VZV Low Run Control
• 00812242030345: VZV Verification Panel
• 00812242030338: Adenovirus High Run Control
• 00812242030321: Adenovirus Low Run Control
• 00812242030314: Adenovirus Verification Panel
• 00812242030307: Zika High Run Control
• 00812242030291: Zika Low Run Control
• 00812242030284: Zika Verification Panel
• 00812242030260: HPV Negative Control
• 00812242030253: HPV Genotype 68 Control
• 00812242030246: HPV Genotype 18 Control
• 00812242030239: HPV Genotype 16 Control
• 00812242030222: HBV Analytical Measurement Range Panel
• 00812242030215: HCV Analytical Measurement Range Panel
• 00812242030208: HIV-1 Analytical Measurement Range Panel