Human Fetal Hemoglobin Test Kit

GUDID 10190302005340

LIFE TECHNOLOGIES CORPORATION

Haemoglobin F (HbF) IVD, kit, electrophoresis

• Primary Device ID: 10190302005340
• NIH Device Record Key: a37e1d0a-6052-4a9a-b6a5-ad2fc542f191
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Human Fetal Hemoglobin Test Kit
• Version Model Number: HFH04
• Company DUNS: 080131636
• Company Name: LIFE TECHNOLOGIES CORPORATION
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190302005340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990641

FDA Product Code

• GHQ: STAIN, FETAL HEMOGLOBIN

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-10-22
• Device Publish Date: 2016-08-01

On-Brand Devices [Human Fetal Hemoglobin Test Kit]

• 10190302005340: HFH04
• 10190302005333: HFH01