DBS Controls M2 3255-0010

GUDID 06438147386956

The DBS Controls M2 is intended for use as an external control material to evaluate the performance of lysosomal enzyme activity. This product has no qualitative or quantitative assigned value. This control is not intended for any specific patient population or specimen.

Wallac Oy

Multiple clinical chemistry enzyme IVD, control

• Primary Device ID: 06438147386956
• NIH Device Record Key: 8301460e-39f9-4b87-8f9d-5a5fb4a5c275
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DBS Controls M2
• Version Model Number: 3255-0010
• Catalog Number: 3255-0010
• Company DUNS: 540156544
• Company Name: Wallac Oy
• 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: true
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -16 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438147386956 [Primary]

FDA Product Code

• OHQ: Multi-Analyte Controls Unassayed

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: 2023-04-25
• Device Publish Date: 2023-04-17

Devices Manufactured by Wallac Oy

• 06438147385478 - RESOLVE Hb FACS Control kit: 2023-04-25 A control for monitoring assay performance in isoelectric focusing techniques used for identifying hemoglobin variants.
• 06438147386918 - Buffer M: 2023-04-25
• 06438147386956 - DBS Controls M2: 2023-04-25The DBS Controls M2 is intended for use as an external control material to evaluate the performance of lysosomal enzyme activity. This product has no qualitative or quantitative assigned value. This control is not intended for any specific patient population or specimen.
• 06438147386956 - DBS Controls M2: 2023-04-25 The DBS Controls M2 is intended for use as an external control material to evaluate the performance of lysosomal enzyme activity
• 06438147386963 - Iduronate 2-sulfatase S&IS: 2023-04-25 Vials contain Iduronate 2-sulfatase -substrate and Iduronate 2-sulfatase -internal standard, which can be used to measure the Id
• 06438147371815 - Qsight 210 MD Screening System: 2023-04-06
• 06438147384709 - Qsight 225 MD Screening System: 2023-04-06
• 06438147373901 - Eonis Analysis software: 2022-12-12 The Eonis Analysis Software is intended for in vitro diagnostic use for analysis of the real time PCR data generated usingthe Eo
• 06438147377718 - Eonis DNA Extraction kit: 2022-12-08 The Eonis DNA Extraction kit is a device intended for isolation and purification of DNA in newborn blood specimens dried on filt