Dried Blood Control 0196

GUDID 04250317552754

MassCheck® Amino Acids, Acylcarnitines EXTENDED Dried Blood Spot Control Level II

Chromsystems Instruments + Chemicals GmbH

Newborn metabolic screen/congenital disorder IVD, control

• Primary Device ID: 04250317552754
• NIH Device Record Key: 69890fa1-ca82-4afe-ab22-7cebe8b2e93e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dried Blood Control
• Version Model Number: 0196
• Catalog Number: 0196
• Company DUNS: 328712260
• Company Name: Chromsystems Instruments + Chemicals GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250317552754 [Primary]

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-08
• Device Publish Date: 2025-07-31

On-Brand Devices [Dried Blood Control]

• 04250317502865: MassCheck® Amino Acids, Acylcarnitines inc. Succinylacetone, Dried Blood Spot Control Level II
• 04250317502841: MassCheck® Amino Acids, Acylcarnitines inc. Succinylacetone, Dried Blood Spot Control Level I
• 04250317554833: MassCheck® Amino Acids, Acylcarnitines EXTENDED incl. Ado, dAdo Dried Blood Spot Control Level
• 04250317554826: MassCheck® Amino Acids, Acylcarnitines EXTENDED incl. Ado, dAdo Dried Blood Spot Control Level
• 04250317554819: MassCheck® Amino Acids, Acylcarnitines EXTENDED incl. Ado, dAdo Dried Blood Spot Control Level
• 04250317552761: MassCheck® Amino Acids, Acylcarnitines EXTENDED Dried Blood Spot Control Level III
• 04250317552754: MassCheck® Amino Acids, Acylcarnitines EXTENDED Dried Blood Spot Control Level II
• 04250317552747: MassCheck® Amino Acids, Acylcarnitines EXTENDED Dried Blood Spot Control Level I