Wallac Plate Shake 1296-004

GUDID 06438147064540

1296-004 DELFIA® Plateshake is intended to be used with DELFIA reagents but can also be used for other applications where shaking of microtitration pl

Wallac Oy

Laboratory shaker

• Primary Device ID: 06438147064540
• NIH Device Record Key: 79a8364a-41f3-4963-9892-2f19b56c0ab6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wallac Plate Shake
• Version Model Number: 1296-004
• Catalog Number: 1296-004
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438147064540 [Primary]

FDA Product Code

• JRQ: Shaker/Stirrer

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: 2019-03-11
• Device Publish Date: 2019-02-25

Devices Manufactured by Wallac Oy

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• 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