Hemoglobin G6PDH Deficient Control HC-108DE

GUDID 00817869020144

ANALYTICAL CONTROL SYSTEMS INC

Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, control

• Primary Device ID: 00817869020144
• NIH Device Record Key: 995eed0a-e918-41c4-87cb-e49d38d4b314
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hemoglobin G6PDH Deficient Control
• Version Model Number: HC-108DE
• Catalog Number: HC-108DE
• Company DUNS: 038232682
• Company Name: ANALYTICAL CONTROL SYSTEMS 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817869020144 [Primary]
GS1	10817869020141 [Package]; Package: 6 pack [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K802569

FDA Product Code

• KHG: Whole Blood Hemoglobin Determination

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: 2019-03-04
• Device Publish Date: 2019-01-31

Devices Manufactured by ANALYTICAL CONTROL SYSTEMS INC

• 00817869020359 - Hemoglobin Variant Control Kit: 2019-11-27
• 00817869020335 - Hemotec Whole Blood Control Kit Large: 2019-11-22 Whole Blood Control Kit containing 8 vials of each: SC-125, SC-126, and DW-101
• 00817869020342 - Hemotec Whole Blood Control Kit Small: 2019-11-22 Whole Blood Control Kit containing 2 vials of each: SC-125, SC-126, and DW-10
• 00817869020311 - Hemotec Whole Blood Control Kit Large: 2019-08-01
• 00817869020007 - .02M Calcium Chloride: 2019-03-04
• 00817869020014 - Slide Platelet Aggregation Test Reagent: 2019-03-04
• 00817869020052 - Hemoglobin AFSC Control: 2019-03-04
• 00817869020069 - Hemoglobin NAFSC Control: 2019-03-04