Amplichek 12000204

GUDID 00847661005957

Amplichek II Level 3 (A nucleic acid control.)

BIO-RAD LABORATORIES, INC.

MRSA nucleic acid IVD, control MRSA nucleic acid IVD, control MRSA nucleic acid IVD, control MRSA nucleic acid IVD, control MRSA nucleic acid IVD, control MRSA nucleic acid IVD, control MRSA nucleic acid IVD, control MRSA nucleic acid IVD, control MRSA nucleic acid IVD, control MRSA nucleic acid IVD, control MRSA nucleic acid IVD, control MRSA nucleic acid IVD, control MRSA nucleic acid IVD, control MRSA nucleic acid IVD, control MRSA nucleic acid IVD, control MRSA nucleic acid IVD, control

• Primary Device ID: 00847661005957
• NIH Device Record Key: f8e420e6-1b30-4580-be73-4d9eafc8cfb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amplichek
• Version Model Number: 12000204
• Catalog Number: 12000204
• 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
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847661005957 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN150058

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: 5
• 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.)