SPOTCHEM™ II Amylase

GUDID 00015482771133

Strip description for the invitro quantitative determination of amylase concentration in human plasma from whole blood samples

ARKRAY USA, INC.

Magnesium (Mg2+) IVD, kit, spectrophotometry

• Primary Device ID: 00015482771133
• NIH Device Record Key: ac7739f9-124a-494c-90ff-6f912a52def9
• Commercial Distribution Discontinuation: 2024-05-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SPOTCHEM™ II Amylase
• Version Model Number: 77113
• 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	00015482771133 [Primary]
GS1	50015482771138 [Unit of Use]

FDA Product Code

• CIJ: SACCHAROGENIC, AMYLASE

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

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