ReliOn™ Fast A1C Test 3055

GUDID 00681131078368

The ReliOn™ Fast A1C Test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples.

WAL-MART STORES, INC.

Glycated haemoglobin (HbA1c) monitoring system IVD, home-use

• Primary Device ID: 00681131078368
• NIH Device Record Key: f9d905ba-f205-446f-b09b-eb4f137c7a20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReliOn™ Fast A1C Test
• Version Model Number: 3055
• Catalog Number: 3055
• Company DUNS: 051957769
• Company Name: WAL-MART STORES, INC.
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• 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: true

Customer Support Contacts

• Phone: 1-855-776-0662
• Email: xx@xx.xx
• Phone: 1-855-776-0662
• Email: xx@xx.xx
• Phone: 1-855-776-0662
• Email: xx@xx.xx
• Phone: 1-855-776-0662
• Email: xx@xx.xx
• Phone: 1-855-776-0662
• Email: xx@xx.xx
• Phone: 1-855-776-0662
• Email: xx@xx.xx
• Phone: 1-855-776-0662
• Email: xx@xx.xx
• Phone: 1-855-776-0662
• Email: xx@xx.xx
• Phone: 1-855-776-0662
• Email: xx@xx.xx
• Phone: 1-855-776-0662
• Email: xx@xx.xx
• Phone: 1-855-776-0662
• Email: xx@xx.xx
• Phone: 1-855-776-0662
• Email: xx@xx.xx
• Phone: 1-855-776-0662
• Email: xx@xx.xx
• Phone: 1-855-776-0662
• Email: xx@xx.xx
• Phone: 1-855-776-0662
• Email: xx@xx.xx
• Phone: 1-855-776-0662
• Email: xx@xx.xx
• Phone: 1-855-776-0662
• Email: xx@xx.xx
• Phone: 1-855-776-0662
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *If you cannot store the kit under these recommended conditions, you may refrigerate the kit (do not freeze). However you must bring the kit to room temperature for at least one hour prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature (64-77 degrees F / 18-25 C) and out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if seal is missing or broken. Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *If you cannot store the kit under these recommended conditions, you may refrigerate the kit (do not freeze). However you must bring the kit to room temperature for at least one hour prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature (64-77 degrees F / 18-25 C) and out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if seal is missing or broken. Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *If you cannot store the kit under these recommended conditions, you may refrigerate the kit (do not freeze). However you must bring the kit to room temperature for at least one hour prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature (64-77 degrees F / 18-25 C) and out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if seal is missing or broken. Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *If you cannot store the kit under these recommended conditions, you may refrigerate the kit (do not freeze). However you must bring the kit to room temperature for at least one hour prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature (64-77 degrees F / 18-25 C) and out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if seal is missing or broken. Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *If you cannot store the kit under these recommended conditions, you may refrigerate the kit (do not freeze). However you must bring the kit to room temperature for at least one hour prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature (64-77 degrees F / 18-25 C) and out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if seal is missing or broken. Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *If you cannot store the kit under these recommended conditions, you may refrigerate the kit (do not freeze). However you must bring the kit to room temperature for at least one hour prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature (64-77 degrees F / 18-25 C) and out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if seal is missing or broken. Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *If you cannot store the kit under these recommended conditions, you may refrigerate the kit (do not freeze). However you must bring the kit to room temperature for at least one hour prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature (64-77 degrees F / 18-25 C) and out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if seal is missing or broken. Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *If you cannot store the kit under these recommended conditions, you may refrigerate the kit (do not freeze). However you must bring the kit to room temperature for at least one hour prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature (64-77 degrees F / 18-25 C) and out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if seal is missing or broken. Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *If you cannot store the kit under these recommended conditions, you may refrigerate the kit (do not freeze). However you must bring the kit to room temperature for at least one hour prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature (64-77 degrees F / 18-25 C) and out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if seal is missing or broken. Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *If you cannot store the kit under these recommended conditions, you may refrigerate the kit (do not freeze). However you must bring the kit to room temperature for at least one hour prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature (64-77 degrees F / 18-25 C) and out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if seal is missing or broken. Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *If you cannot store the kit under these recommended conditions, you may refrigerate the kit (do not freeze). However you must bring the kit to room temperature for at least one hour prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature (64-77 degrees F / 18-25 C) and out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if seal is missing or broken. Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *If you cannot store the kit under these recommended conditions, you may refrigerate the kit (do not freeze). However you must bring the kit to room temperature for at least one hour prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature (64-77 degrees F / 18-25 C) and out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if seal is missing or broken. Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *If you cannot store the kit under these recommended conditions, you may refrigerate the kit (do not freeze). However you must bring the kit to room temperature for at least one hour prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature (64-77 degrees F / 18-25 C) and out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if seal is missing or broken. Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *If you cannot store the kit under these recommended conditions, you may refrigerate the kit (do not freeze). However you must bring the kit to room temperature for at least one hour prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature (64-77 degrees F / 18-25 C) and out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if seal is missing or broken. Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *If you cannot store the kit under these recommended conditions, you may refrigerate the kit (do not freeze). However you must bring the kit to room temperature for at least one hour prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature (64-77 degrees F / 18-25 C) and out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if seal is missing or broken. Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *If you cannot store the kit under these recommended conditions, you may refrigerate the kit (do not freeze). However you must bring the kit to room temperature for at least one hour prior to use.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature (64-77 degrees F / 18-25 C) and out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if seal is missing or broken. Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681131078368 [Primary]
GS1	10681131078365 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090413

FDA Product Code

• LCP: Assay, Glycosylated Hemoglobin

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: 2016-09-01

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