ABORhCard BT-101-025

GUDID 00815312020000

Qualitative in vitro test that provides a simultaneous ABO and Rh determination of an individual's ABO and Rh status. Not for use in blood bank processing of blood products, for determining RHD status for the purpose of administering Rh immunoglobulin, or for screening purposes prior to transfusion. Single use device intended for individual blood group determination for educational and informational purposes. Each kit contains 25 tests.

MICRONICS, INC.

ABO/Rh(D) multiple blood grouping IVD, kit, agglutination

• Primary Device ID: 00815312020000
• NIH Device Record Key: 72bfec55-35dd-4a06-abf9-e720c6e8f824
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABORhCard
• Version Model Number: BT-101-025
• Catalog Number: BT-101-025
• Company DUNS: 799245519
• Company Name: MICRONICS, INC.
• Device Count: 25
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-855-895-9197
• Email: support@micronics.net
• Phone: 1-855-895-9197
• Email: support@micronics.net
• Phone: 1-855-895-9197
• Email: support@micronics.net
• Phone: 1-855-895-9197
• Email: support@micronics.net
• Phone: 1-855-895-9197
• Email: support@micronics.net
• Phone: 1-855-895-9197
• Email: support@micronics.net
• Phone: 1-855-895-9197
• Email: support@micronics.net
• Phone: 1-855-895-9197
• Email: support@micronics.net
• Phone: 1-855-895-9197
• Email: support@micronics.net
• Phone: 1-855-895-9197
• Email: support@micronics.net
• Phone: 1-855-895-9197
• Email: support@micronics.net
• Phone: 1-855-895-9197
• Email: support@micronics.net
• Phone: 1-855-895-9197
• Email: support@micronics.net
• Phone: 1-855-895-9197
• Email: support@micronics.net
• Phone: 1-855-895-9197
• Email: support@micronics.net
• Phone: 1-855-895-9197
• Email: support@micronics.net
• Phone: 1-855-895-9197
• Email: support@micronics.net
• Phone: 1-855-895-9197
• Email: support@micronics.net
• Phone: 1-855-895-9197
• Email: support@micronics.net

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *store at room temperatuire
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperatuire
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperatuire
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperatuire
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperatuire
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperatuire
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperatuire
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperatuire
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperatuire
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperatuire
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperatuire
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperatuire
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperatuire
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperatuire
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperatuire
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperatuire
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperatuire

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815312020000 [Primary]
GS1	00815312020048 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• BK100008

FDA Product Code

• OQX: Self-Contained Blood Grouping

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: 2016-09-23