Leptopspira IgG ELISA EIA-4245

GUDID 00840239042453

The Leptospira IgG ELISA test is an enzyme immunoassay for the detection of antibodies to Leptospira biflexa (serovar patoc 1) for the serological confirmation of infections in serum and plasma.

DRG International Inc

Multiple Leptospira species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00840239042453
• NIH Device Record Key: 5eec9cbe-61fe-4c3c-8b1b-72a5a4e2d457
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leptopspira IgG ELISA
• Version Model Number: EIA-4245
• Catalog Number: EIA-4245
• Company DUNS: 075150847
• Company Name: DRG International 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: 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

Customer Support Contacts

• Phone: +1(973)564-7555
• Email: corp@drg-international.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840239042453 [Primary]

FDA Product Code

• GRY: ANTIGENS, ALL, LEPTOSPIRA SPP.

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: 2020-03-30
• Device Publish Date: 2019-06-05

Devices Manufactured by DRG International Inc

• 00840239035769 - Anti-SS-B ELISA: 2023-10-17 Anti-SS-B ELISA is a test system for the quantitative measurement of IgG class autoantibodies against SS-B (La) in human serum o
• 00840239048882 - Vitamin C (Ascorbic Acid): 2023-09-11 This colorimetric microtiter plate assay is suitable for the determination of vitamin C (ascorbic acid) in Li-heparin plasma, se
• 00084023903579 - Anti-SS-B ELISA: 2023-09-04 Anti-SS-B ELISA is a test system for the quantitative measurement of IgG class autoantibodies against SS-B (La) in human serum o
• 00840239029317 - Salivary Progesterone ELISA: 2023-09-04 Enzyme immunoassay for the in vitro diagnostic quantitative measurement of active free progesterone (a female hormone) in saliva
• 00840239030139 - Salivary Testosterone ELISA: 2023-09-04 The Salivary Testosterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active tes
• 00840239031402 - Salivary 17-OH Progesterone ELISA: 2023-09-04 An enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free 17-a-hydroxyprogesterone in saliva.
• 00840239035776 - Anti-Sm ELISA: 2023-09-04 Anti-Sm ELISA is a test system for the quantitative measurement of IgG class autoantibodies against Sm in human serum or plasma.
• 00840239035783 - Anti-RNP/Sm ELISA: 2023-09-04 Anti-RNP/Sm ELISA is a test system for the quantitative measurement of IgG class autoantibodies against RNP/Sm in human serum or