Amplichek 12000529

GUDID 03610520530078

Amplichek I Level 2 (An assayed nucleic acid control.)

BIO-RAD LABORATORIES, INC.

HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

• Primary Device ID: 03610520530078
• NIH Device Record Key: 44630c18-b546-4367-8b08-35e65b9c9c61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amplichek
• Version Model Number: 12000529
• Catalog Number: 12000529
• Company DUNS: 051624070
• Company Name: BIO-RAD LABORATORIES, 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: false
• 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

Customer Support Contacts

• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03610520530078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152679

FDA Product Code

• PMN: Assayed external control material for microbiology nucleic acid amplification (NAT) assays

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-23
• Device Publish Date: 2016-09-19

On-Brand Devices [Amplichek]

• 00847661005995: Amplichek II Level 3 MiniPak (A nucleic acid control.)
• 00847661005988: Amplichek II Level 2 MiniPak (A nucleic acid control.)
• 00847661005971: Amplichek II Level 1 MiniPak (A nucleic acid control.)
• 00847661005964: Amplichek II Negative MiniPak (A nucleic acid control.)
• 00847661005957: Amplichek II Level 3 (A nucleic acid control.)
• 00847661005940: Amplichek II Level 2 (A nucleic acid control.)
• 00847661005933: Amplichek II Level 1 (A nucleic acid control.)
• 00847661005926: Amplichek II Negative (A nucleic acid control.)
• 03610520530092: Amplichek I MiniPak (An assayed nucleic acid control.)
• 03610520530085: Amplichek I Level 3 (An assayed nucleic acid control.)
• 03610520530078: Amplichek I Level 2 (An assayed nucleic acid control.)
• 03610520530061: Amplichek I Level 1 (An assayed nucleic acid control.)
• 03610520530054: Amplichek I Negative (An assayed nucleic acid control.)