Diazyme

GUDID 00817089020016

DIAZYME LABORATORIES, INC.

Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 00817089020016
• NIH Device Record Key: 0278dfca-f379-4200-87ef-47f134f08388
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diazyme
• Version Model Number: DZ141A-K
• Company DUNS: 080507219
• Company Name: DIAZYME 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817089020016 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-11-03

On-Brand Devices [Diazyme]

• 00817089021457: DZ568A-KD2
• 00817089021297: DZ568A-K07
• 00817089021280: DZ135B-SMA
• 00817089021273: DZ122A-KY2
• 00817089021266: DZ122A-KB1
• 00817089021259: DZ116B-KH1
• 00817089021242: DZ116B-KB1
• 00817089021235: DZ114B-K01
• 00817089021228: DZ113C-K01
• 00817089021211: DZ042A-K01
• 00817089021204: DZ042A-KY1
• 00817089021198: DZ042A-KB1
• 00817089021181: DZ132A-KY1
• 00817089021174: DZ133D-SMA
• 00817089021167: DZ133C-KY2
• 00817089021150: DZ133C-KY1
• 00817089021143: DZ133C-KD1
• 00817089021136: DZ133C-KB1
• 00817089021129: DZ072B-KY1
• 00817089021112: DZ865A-KY1
• 00817089021105: DZ112B-SMA
• 00817089021099: DZ112B-KY1
• 00817089021082: DZ168B-POC
• 00817089021075: DZ168A-KY2
• 00817089021068: DZ168A-KD1
• 00817089021051: DZ168A-KB1
• 00817089021044: DZ128A-KD1
• 00817089021037: DZ128A-KY1
• 00817089021020: DZ128A-KB1
• 00817089021013: DZ129A-KD1
• 00817089020993: DZ129A-KB1
• 00817089020986: DZ131A-KY1
• 00817089020979: DZ131A-KB1
• 00817089020962: DZ568B-SMA
• 00817089020955: DZ568B-BY2
• 00817089020948: DZ568B-BY1
• 00817089020894: DZ568A-K05
• 00817089020887: DZ568A-K04
• 00817089020870: DZ568A-K03
• 00817089020863: DZ141A-CAL
• 00817089020856: DZ130A-CAL
• 00817089020818: DZ123A-CON
• 00817089020801: DZ123A-CAL
• 00817089020795: DZ123A-K
• 00817089020788: DZ132A-CON
• 00817089020771: DZ132A-CAL
• 00817089020764: DZ132A-K
• 00817089020757: DZ865A-CON
• 00817089020740: DZ865A-CAL
• 00817089020733: DZ865A-K