Baebies 6-HMU GALC 2103

GUDID 00819704020265

6-HMU GALC Substrate. Analyte Specific Reagent - Analytical and performance characteristics are not established.

BAEBIES, INC.

Newborn metabolic screen/congenital disorder IVD, reagent

• Primary Device ID: 00819704020265
• NIH Device Record Key: 61964cb8-07eb-47c2-8b60-a90fd2502630
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Baebies 6-HMU GALC
• Version Model Number: 2103
• Catalog Number: 2103
• Company DUNS: 079264306
• Company Name: BAEBIES, INC.
• 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: true
• 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: 844-244-4034
• Email: techsupport@baebies.com
• Phone: 844-244-4034
• Email: techsupport@baebies.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -80 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819704020265 [Primary]
GS1	10819704020262 [Package]; Package: Box [12 Units]; In Commercial Distribution

FDA Product Code

• MVU: Reagents, Specific, Analyte

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: 2019-01-14
• Device Publish Date: 2018-12-12

Devices Manufactured by BAEBIES, INC.

• 00819704020265 - Baebies 6-HMU GALC: 2019-01-146-HMU GALC Substrate. Analyte Specific Reagent - Analytical and performance characteristics are not established.
• 00819704020265 - Baebies 6-HMU GALC: 2019-01-14 6-HMU GALC Substrate. Analyte Specific Reagent - Analytical and performance characteristics are not established.
• 10819704020279 - Baebies Stop Solution: 2019-01-14 Baebies Stop Solution General Purpose Reagent, For Laboratory Use.
• 00819704020289 - Baebies 6-HMU Dilution Set: 2019-01-14 6-HMU Dilution Set General Purpose Reagent, For Laboratory Use.
• 10819704020293 - Baebies Extraction Solution: 2019-01-14 Baebies Extraction Solution General Purpose Reagent, For Laboratory Use
• 00819704020197 - SEEKER™: 2019-01-04 The SEEKER™ Instrument is a quantitative in vitro diagnostic instrument for the determination of clinical chemistry analytes.
• 00819704020203 - SEEKER™: 2019-01-04 SEEKER™ Instrument & Accessories The SEEKER™ Instrument is a quantitative in vitro diagnostic instrument for the determinati
• 10819704020309 - Baebies 4-MU IDS: 2018-11-05 4-MU IDS Reagent Tube, 4.3mL Analyte Specific Reagent - Analytical and performance characteristics are not established.
• 10819704020316 - Baebies 4-MU Dilution Set: 2018-11-05 4-MU Dilution Set General Purpose Reagent, For Laboratory Use.