CRYPTOSPORIDIUM II

GUDID 00857031002035

The CRYPTOSPORIDIUM II test is an enzyme immunoassay for the qualitative detection of Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Cryptosporidium gastrointestinal infection.

TECHLAB, INC.

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

• Primary Device ID: 00857031002035
• NIH Device Record Key: bb65abcf-eb20-42ad-b401-18fd08c23431
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRYPTOSPORIDIUM II
• Version Model Number: 30406
• Company DUNS: 614218634
• Company Name: TECHLAB, 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857031002035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052932

FDA Product Code

• MHJ: Cryptosporidium 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-23

On-Brand Devices [CRYPTOSPORIDIUM II]

• 00857031002301: The CRYPTOSPORIDIUM II test is an enzyme immunoassay for the qualitative detection of Cryptospor
• 00857031002035: The CRYPTOSPORIDIUM II test is an enzyme immunoassay for the qualitative detection of Cryptospor