Pointe Lactate Dehydrogenase Reagent 16-HL956-236

GUDID 00811727016201

Pointe Lactate Dehydrogenase Reagent packaged for use on the Mindray BA800. 4 x 42ml R1, 4 x 17ml R2. For the quantitative kinetic determination of lactate dehydrogenase activity in serum. For in vitro diagnostic use only.

POINTE SCIENTIFIC, INC.

Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent

• Primary Device ID: 00811727016201
• NIH Device Record Key: 6e8b8091-7700-4129-b7da-7470173ede0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pointe Lactate Dehydrogenase Reagent
• Version Model Number: 16-HL956-236
• Catalog Number: 16-HL956-236
• Company DUNS: 045623154
• Company Name: POINTE SCIENTIFIC, 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811727016201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973589

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-08
• Device Publish Date: 2021-01-30

On-Brand Devices [Pointe Lactate Dehydrogenase Reagent]

• 00811727016201: Pointe Lactate Dehydrogenase Reagent packaged for use on the Mindray BA800. 4 x 42ml R1, 4 x 1
• 00811727015907: Pointe Lactate Dehydrogenase Reagent packaged for use on the Mindray BS480. 4 x 40ml R1, 4 x 10m