LDH Liqui-UV® 2940-430

GUDID 00657498000946

For the Quantitative Determination of Lactate Dehydrogenase in Serum and EDTA Plasma.

STANBIO LABORATORY, L.P.

Total lactate dehydrogenase (LDH) IVD, kit, enzyme spectrophotometry Total lactate dehydrogenase (LDH) IVD, kit, enzyme spectrophotometry Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry

• Primary Device ID: 00657498000946
• NIH Device Record Key: ce532b88-d768-4baf-8db3-d344f8ead318
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LDH Liqui-UV®
• Version Model Number: 2940-430
• Catalog Number: 2940-430
• Company DUNS: 045361136
• Company Name: STANBIO LABORATORY, L.P.
• 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: 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

Customer Support Contacts

• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com

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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00657498000946 [Primary]

FDA Product Code

• CFJ: Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

On-Brand Devices [LDH Liqui-UV®]

• 00657498000953: For the Quantitative Determination of Lactate Dehydrogenase in Serum and EDTA Plasma.
• 00657498000946: For the Quantitative Determination of Lactate Dehydrogenase in Serum and EDTA Plasma.