SPOTCHEM™ II Triglycerides

GUDID 00015482771041

Strip is for invitro quantitative determination of triglycerides in human plasma from whole blood samples

ARKRAY USA, INC.

Magnesium (Mg2+) IVD, kit, spectrophotometry

• Primary Device ID: 00015482771041
• NIH Device Record Key: 4ef92bea-8a97-419b-9dd2-22959c7a64f3
• Commercial Distribution Discontinuation: 2024-05-29
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SPOTCHEM™ II Triglycerides
• Version Model Number: 77104
• Company DUNS: 008171162
• Company Name: ARKRAY USA, 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: false

Customer Support Contacts

• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx

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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015482771041 [Primary]
GS1	50015482771046 [Unit of Use]

FDA Product Code

• CHH: ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-05-31
• Device Publish Date: 2016-09-23

Devices Manufactured by ARKRAY USA, INC.

• 00015482117313 - AUTION MAX™ AX-4060 Analyzer: 2024-12-10 The AUTION MAX AX-4060 urine analyzer, when used with AUTION Sticks 9EB test strips is a fully automated urinalysis sytem intend
• 00015482117344 - AUTION™ Sticks 9EB - Test Strips: 2024-12-10 AUTION Sticks 9EB test strips are test strips for the in vitro qualitative or semi-quantitative measurement of the following ana
• 00015482181550 - AUTION EYE™ Sheath Solution - 10L Bottle: 2024-12-10 AUTION EYE Sheath Solution is intended for in vitro diagnostic use with the AUTION EYE AI-4510 analyzer to identify formed parti
• 00015482181574 - AUTION EYE™ Control Solution H/L: 2024-12-10 AUTION EYE Control Solution H/L is intended for in vitro diagnostic use only for performing quality control procedures with the
• 00015482181598 - AUTION EYE™ Calibrator Focus/Calibrator: 2024-12-10 AUTION EYE Calibrator is intended for in vitro diagnostic use only for focusing and calibrating the AUTION EYE AI-4510.
• 00015482188627 - AUTION EYE™ AI-4510 Analyzer: 2024-12-10 The AUTION EYE AI-4510 Urine Particle Analysis System is a fully automated urine particle analyzer for in vitro diagnostic use.
• 14987486005299 - Concentrated Washing Solution 3: 2024-12-10 A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated ins
• 00015482183103 - SPOTCHEM™ EZ Analyzer: 2024-05-31 Dry Chemistry Analyzer IVD, semi-automated