Enzymer ER Verifier, Level G

GUDID 00852553007131

Calibration Verification

VERICHEM LABORATORIES, INC.

Multiple clinical chemistry enzyme IVD, control Multiple clinical chemistry enzyme IVD, control Multiple clinical chemistry enzyme IVD, control Multiple clinical chemistry enzyme IVD, control Multiple clinical chemistry enzyme IVD, control Multiple clinical chemistry enzyme IVD, control Multiple clinical chemistry enzyme IVD, control Multiple clinical chemistry enzyme IVD, control Multiple clinical chemistry enzyme IVD, control

• Primary Device ID: 00852553007131
• NIH Device Record Key: 1f4d990f-a62d-4032-b015-3cf59bb017e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enzymer ER Verifier, Level G
• Version Model Number: 9417
• Company DUNS: 189023351
• Company Name: VERICHEM LABORATORIES, 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: 1-800-552-5859
• Email: customerservice@verichemlabs.com
• Phone: 1-800-552-5859
• Email: customerservice@verichemlabs.com
• Phone: 1-800-552-5859
• Email: customerservice@verichemlabs.com
• Phone: 1-800-552-5859
• Email: customerservice@verichemlabs.com
• Phone: 1-800-552-5859
• Email: customerservice@verichemlabs.com
• Phone: 1-800-552-5859
• Email: customerservice@verichemlabs.com
• Phone: 1-800-552-5859
• Email: customerservice@verichemlabs.com
• Phone: 1-800-552-5859
• Email: customerservice@verichemlabs.com
• Phone: 1-800-552-5859
• Email: customerservice@verichemlabs.com

Device Dimensions

• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852553007131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K880266

FDA Product Code

• JJT: Enzyme Controls (Assayed And Unassayed)

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: 2016-11-29

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