Leptopspira IgG ELISA EIA-5751

GUDID 00404847457513

The Leptospira IgG ELISA is intended for the qualitative determination of IgG class antibodies against Leptospira spp. in human serum or plasma (heparin).

DRG Instruments Gesellschaft mit beschränkter Haftung

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

• Primary Device ID: 00404847457513
• NIH Device Record Key: da629c34-5a54-437a-9e00-8e9de5305a93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leptopspira IgG ELISA
• Version Model Number: N/A
• Catalog Number: EIA-5751
• Company DUNS: 317134468
• Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung
• 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	00404847457513 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-18
• Device Publish Date: 2019-06-10

On-Brand Devices [Leptopspira IgG ELISA]

• 00404847457513: The Leptospira IgG ELISA is intended for the qualitative determination of IgG class antibodies a
• 04048474057515: The Leptospira IgG ELISA is intended for the qualitative determination of IgG class antibodies a