AUTION™ Diluent BAC

GUDID 04987486738084

Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Cells, and Bacteria as well as flags for pathologic casts, yeast, cry

ARKRAY USA, INC.

Urine analyser IVD, laboratory, automated Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory

• Primary Device ID: 04987486738084
• NIH Device Record Key: dc692fa1-78f5-4e6b-b836-7d5c1c617440
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUTION™ Diluent BAC
• Version Model Number: 73808
• Company DUNS: 008171162
• Company Name: ARKRAY USA, 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: false
• 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(855)646-3108
• Email: xxx@xxx.xxx
• Phone: +1(855)646-3108
• Email: xxx@xxx.xxx
• Phone: +1(855)646-3108
• Email: xxx@xxx.xxx
• Phone: +1(855)646-3108
• Email: xxx@xxx.xxx
• Phone: +1(855)646-3108
• Email: xxx@xxx.xxx
• Phone: +1(855)646-3108
• Email: xxx@xxx.xxx
• Phone: +1(855)646-3108
• Email: xxx@xxx.xxx
• Phone: +1(855)646-3108
• Email: xxx@xxx.xxx
• Phone: +1(855)646-3108
• Email: xxx@xxx.xxx
• Phone: +1(855)646-3108
• Email: xxx@xxx.xxx
• Phone: +1(855)646-3108
• Email: xxx@xxx.xxx
• Phone: +1(855)646-3108
• Email: xxx@xxx.xxx
• Phone: +1(855)646-3108
• Email: xxx@xxx.xxx
• Phone: +1(855)646-3108
• Email: xxx@xxx.xxx
• Phone: +1(855)646-3108
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987486738084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121456

FDA Product Code

• KQO: AUTOMATED URINALYSIS SYSTEM

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

Devices Manufactured by ARKRAY USA, INC.

• 50015482234237 - TechLITE PLUS PEN NEEDLES: 2024-03-19 Insulin Pen Needle. Intended for use with a pen injector device for the subcutaneous injection of insulin.
• 10015482880160 - TechLITE® Lancets, 26g: 2023-10-05 TechLITE Lancets 26g 100's. The lancet is intended for capillary blood sampling.
• 00015482880187 - TechLITE® Lancets, 28g: 2023-09-27 TechLITE Lancets 28g 100's. The lancet is intended for capillary blood sampling.
• 10015482232297 - TechLITE PEN NEEDLES: 2023-09-08 Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneous injection of drugs.
• 10015482234321 - TechLITE PEN NEEDLES: 2023-09-08 Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneous injection of drugs.
• 10015482235311 - TechLITE PEN NEEDLES: 2023-09-08 Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneous injection of drugs.
• 10015482236325 - TechLITE PEN NEEDLES: 2023-09-08 Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneous injection of drugs.
• 10015482238312 - TechLITE PEN NEEDLES: 2023-09-08 Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneous injection of drugs.