Cryptosporidium Antigen (stool) ELISA EIA-3467

GUDID 00840239034670

This ELISA is an in vitro immunoassay for the qualitative determination of Cryptosporidium antigen in fecal specimens

DRG International Inc

Cryptosporidium species antigen IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00840239034670
• NIH Device Record Key: e5aaf978-4e91-4d78-9d0f-b9195ea5aedb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cryptosporidium Antigen (stool) ELISA
• Version Model Number: EIA-3467
• Catalog Number: EIA-3467
• 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: true
• 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: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@drg-international.com

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840239034670 [Primary]

FDA Product Code

• MHJ: Cryptosporidium 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: 2023-09-01
• Device Publish Date: 2023-08-24

Devices Manufactured by DRG International Inc

• 00840239023858 - Free Triiodothyronine (fT3) ELISA: 2024-10-01 For the quantitative determination of Free Triiodothyronine (fT3) concentration in human serum
• 00840239038012 - Free T3 ELISA: 2024-10-01 The DRG Free T3 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free triiodothyronine (FT
• 00840239053565 - T3 free: 2024-10-01 The DRG:HYBRiD-XL free T3 is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free Triiodothyronine
• 00840239038470 - Mumps IgM ELISA: 2024-08-28 The Mumps Virus IgM ELISA is intended for the qualitative determination of IgM class antibodies against Mumps Virus in human ser
• 00840239056979 - T-3: 2024-08-21 The DRG:Hybrid-XL T3 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of T3
• 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