Microorganism Pellets URI-KIT

GUDID 10634853000589

Culture Control Kit for Uricult

MICROBIOLOGICS INC.

Multiple urine analyte IVD, control

• Primary Device ID: 10634853000589
• NIH Device Record Key: f7f450e3-2f46-4028-b924-b95dbaf8541a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Microorganism Pellets
• Version Model Number: URI-KIT
• Catalog Number: URI-KIT
• Company DUNS: 060467826
• Company Name: MICROBIOLOGICS 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10634853000589 [Primary]

FDA Product Code

• JTR: Kit, quality control for culture media

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: 2022-10-04
• Device Publish Date: 2022-09-26

Devices Manufactured by MICROBIOLOGICS INC.

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• 70845357044364 - QC Sets and Panels: Helix Elite™: 2024-09-12 QC Sets and Panels: Helix Elite™ Rapid SARS-CoV-2 Control Panel
• 70845357044388 - QC Sets and Panels: Helix Elite™: 2024-03-26 QC Sets and Panels: Helix Elite™ Flu/RSV/SARS-CoV-2 Control Panel Sample Kit
• 10634853000138 - Fungal Serology: 2022-10-04 Immunodiffusion Agar Plates, 1 - 7 Well Pattern
• 10634853000145 - Fungal Serology: 2022-10-04 Immunodiffusion Agar Plates, 3 - 7 Well Pattern
• 10634853000152 - Fungal Serology: 2022-10-04 Immunodiffusion Agar Plates, 8 - 7 Well Pattern
• 10634853000169 - Fungal Serology: 2022-10-04 Normal Rabbit Serum (Negative), 1mL
• 10634853000176 - Fungal Serology: 2022-10-04 Clarifying Reagent (Sodium Citrate), 20mL