VITROS 6800880

GUDID 10758750001002

VITROS Immunodiagnostic Products CA 125 II™ Range Verifiers

ORTHO CLINICAL DIAGNOSTICS

Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 10758750001002
• NIH Device Record Key: f0758d25-1008-4b45-a121-f96cc8939415
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VITROS
• Version Model Number: 6800880
• Catalog Number: 6800880
• Company DUNS: 215865786
• Company Name: ORTHO CLINICAL DIAGNOSTICS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10758750001002 [Primary]
GS1	20758750001009 [Package]; Package: Case [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990783

FDA Product Code

• JJX: Single (specified) analyte controls (assayed and unassayed)

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: 2020-04-16
• Device Publish Date: 2020-04-08

On-Brand Devices [VITROS]

• 10758750002801: VITROS Immunodiagnostic Products Anti-HCV Reagent Pack
• 10758750002795: VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack
• 10758750002788: VITROS Immunodiagnostic Products Anti-HBs Reagent Pack
• 10758750002771: VITROS Immunodiagnostic Products Anti-HBc Reagent Pack
• 10758750002764: VITROS Immunodiagnostic Products HBsAg Reagent Pack
• 10758750001699: VITROS Immunodiagnostic Products Anti-HBs Calibrator
• 10758750001682: VITROS Immunodiagnostic Products Anti-HBs Reagent Pack
• 10758750001538: VITROS Immunodiagnostic Products Anti-HIV 1+2 Calibrator
• 10758750001521: VITROS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack
• 10758750001453: VITROS Immunodiagnostic Products HBeAg Calibrator
• 10758750001446: VITROS Immunodiagnostic Products HBeAg Reagent Pack
• 10758750001439: VITROS Immunodiagnostic Products Anti-HBe Calibrator
• 10758750001422: VITROS Immunodiagnostic Products Anti-HBe Reagent Pack
• 10758750001224: VITROS Immunodiagnostic Products Anti-HBc Calibrator
• 10758750001217: VITROS Immunodiagnostic Products Anti-HBc Reagent Pack
• 10758750001194: VITROS Immunodiagnostic Products Anti-HBc IgM Calibrator
• 10758750001187: VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack
• 10758750001101: VITROS Immunodiagnostic Products Anti-HCV Calibrator
• 10758750001095: VITROS Immunodiagnostic Products Anti-HCV Reagent Pack
• 10758750001088: VITROS Immunodiagnostic Products HBsAg Confirmatory Kit
• 10758750001071: VITROS Immunodiagnostic Products HBsAg Calibrator
• 10758750001064: VITROS Immunodiagnostic Products HBsAg Reagent Pack
• 10758750031597: VITROS Immunodiagnostic Products HIV Combo Calibrator
• 10758750031580: VITROS Immunodiagnostic Products HIV Combo Reagent Pack
• 10758750006267: VITROS Immunodiagnostic Products Intact PTH Reagent Pack
• 10758750006250: VITROS Immunodiagnostic Products Intact PTH Calibrators
• 10758750001309: VITROS Immunodiagnostic Products PSA Reagent Pack
• 10758750000319: VITROS Immunodiagnostic Products PSA Calibrators
• 10758750009077: VITROS Immunodiagnostic Products Testosterone Reagent Pack
• 10758750008902: VITROS Immunodiagnostic Products LH Reagent Pack
• 10758750006243: VITROS Immunodiagnostic Products Intact PTH Range Verifier
• 10758750006236: VITROS Immunodiagnostic Products Intact PTH Controls
• 10758750005017: VITROS Immunodiagnostic Products Estradiol Reagent Pack
• 10758750001156: VITROS Immunodiagnostic Products Anti-HCV Controls
• 10758750001149: VITROS Immunodiagnostic Products HBsAg Controls
• 10758750000845: VITROS Immunodiagnostic Products Testosterone Range Verifiers
• 10758750000814: VITROS Immunodiagnostic Products Estradiol Range Verifiers
• 10758750000777: VITROS Immunodiagnostic Products Prolactin Range Verifiers
• 10758750000760: VITROS Immunodiagnostic Products FSH Range Verifiers
• 10758750000753: VITROS Immunodiagnostic Products LH Range Verifiers
• 10758750000500: VITROS Immunodiagnostic Products NTx Reagent Pack
• 10758750000333: VITROS Immunodiagnostic Products Progesterone Reagent Pack
• 10758750000302: VITROS Immunodiagnostic Products FSH Reagent Pack
• 10758750000111: VITROS Immunodiagnostic Products Prolactin Reagent Pack
• 10758750009411: VITROS Immunodiagnostic Products Anemia Controls
• 10758750009053: VITROS Immunodiagnostic Products Metabolism Controls
• 10758750009015: VITROS Immunodiagnostic Products Total Thyroid Controls
• 10758750008803: VITROS Immunodiagnostic Products Free Thyroid Controls
• 10758750008322: VITROS Immunodiagnostic Products RE Controls
• 10758750002528: VITROS Immunodiagnostic Products Troponin I ES Range Verifiers