Alk Phos R2 (w/ssa#) 13-A7516-R2-30

GUDID 00811727013743

For the quantitative determination of Alanine Aminotransferase in serum.

POINTE SCIENTIFIC, INC.

Total alkaline phosphatase (ALP) IVD, kit, enzyme spectrophotometry Total alkaline phosphatase (ALP) IVD, kit, enzyme spectrophotometry Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry

• Primary Device ID: 00811727013743
• NIH Device Record Key: 2ca77517-482c-492b-af0d-be5e6ed074b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alk Phos R2 (w/ssa#)
• Version Model Number: 13-A7516-R2-30
• Catalog Number: 13-A7516-R2-30
• 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@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.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	00811727013743 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973588

FDA Product Code

• CJE: Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

On-Brand Devices [Alk Phos R2 (w/ssa#)]

• 00811727013743: For the quantitative determination of Alanine Aminotransferase in serum.
• 00811727013736: For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnos