Antiserum to Human Alpha 1 Acid Glycoprotein 123002

GUDID B1761230

Goat antiserum to Human Alpha 1 Acid Glycoprotein

KENT LABORATORIES INC

Alpha-1-acid glycoprotein (orosomucoid) IVD, reagent Alpha-1-acid glycoprotein (orosomucoid) IVD, reagent

• Primary Device ID: B1761230
• NIH Device Record Key: 1cdee40b-d2c4-4bcb-bb34-e4ed6b2f5784
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Antiserum to Human Alpha 1 Acid Glycoprotein
• Version Model Number: 1
• Catalog Number: 123002
• Company DUNS: 093642254
• Company Name: KENT 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B1761230 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K831960

FDA Product Code

• LKL: Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by KENT LABORATORIES INC

• B1761080 - Antiserum to Human Properdin: 2018-09-12 Goat antiserum to human Properdin
• B1761082 - Anti Human Properdin FITC: 2018-09-12 Fluorescein conjugated polyclonal goat antiserum to Human Complement Properdin
• B1761210 - Antiserum to Human C-3b Inactivator (factor I): 2018-09-12 Goat antiserum to Human C-3b Inactivator (factor I)
• B1761212 - Anti Human C3b Inactivator FITC: 2018-09-12 Fluorescein conjugated polyclonal goat antiserum to Human C3b Inactivator
• B1761230 - Antiserum to Human Alpha 1 Acid Glycoprotein: 2018-07-06Goat antiserum to Human Alpha 1 Acid Glycoprotein
• B1761230 - Antiserum to Human Alpha 1 Acid Glycoprotein: 2018-07-06 Goat antiserum to Human Alpha 1 Acid Glycoprotein
• B176131 - Antiserum to Human Myoglobin: 2018-07-06
• B1761500 - Antiserum to Apolipoprotein A-1: 2018-07-06
• B1761520 - Antiserum to Apolipprotein B: 2018-07-06