ELISA Cardiolipin IgG/IgM/IgA Smart Kit Test System SM2Z51051

GUDID 00845533000352

The ZEUS ELISA Cardiolipin IgG/IgM/IgA Test System is intended for the in vitro, qualitative measurement of IgG, IgM and/or IgA antibodies directed to Cardiolipin in human serum to aid in the diagnosis of primary antiphospholipid syndrome (PAPS) and secondary antiphospholipid syndrome (SAPS) in conjunction with other laboratory and clinical findings.

ZEUS SCIENTIFIC, INC.

Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00845533000352
• NIH Device Record Key: 6b567505-100a-4334-86c5-5c90e0640385
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELISA Cardiolipin IgG/IgM/IgA Smart Kit Test System
• Version Model Number: SM2Z51051
• Catalog Number: SM2Z51051
• Company DUNS: 080953946
• Company Name: ZEUS SCIENTIFIC, INC.
• 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: 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845533000352 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

Devices Manufactured by ZEUS SCIENTIFIC, INC.

• 00845533001892 - ANA HEp-2: 2024-12-27 The ANA HEp-2 Test System is a pre-standardized assay designed for the qualitative and semi-quantitative detection of antinuclea
• 00845533001908 - dsDNA (Crithidia l.): 2024-12-27 The dsDNA (Crithidia l.) kit is a pre-standardized assay designed for the qualitative and semi-quantitative detection of antibod
• 00845533001915 - Rat Kidney/Stomach Tissue: 2024-12-27 The Rat Kidney/Stomach Tissue kit is designed for the qualitative and semi-quantitative detection of antinuclear, mitochondrial,
• 00845533001922 - Rat Kidney/Stomach/Liver Tissue: 2024-12-27 The Rat Kidney/Stomach/Liver Tissue kit is designed for the qualitative and semi-quantitative detection of antinuclear, mitochon
• 00845533001939 - Mouse Kidney/Stomach/Liver Tissue: 2024-12-27 The Mouse Kidney/Stomach/Liver Tissue kit is designed for the qualitative and semi-quantitative detection of antinuclear, mitoch
• 00845533001946 - ASA (Monkey Esophagus): 2024-12-27 The ASA (Monkey Esophagus) kit is designed for the qualitative and semi-quantitative detection of antibodies associated with Pem
• 00845533001885 - ZEUS ELISA VZV IgM 480 Test System: 2024-09-26 The ZEUS ELISA Varicella-Zoster Virus (VZV) IgM Test System is intended for the qualitative detection of VZV IgM antibody inhuma
• 00845533001878 - ZEUS NTx Urine: 2023-04-26 An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen