MP Biomedicals LLC 07189105

GUDID 00817830023211

IMMUCHEM DOUBLE ANTIBODY TESTOSTERONE 125I 500 TUBE KIT

Mp Biomedicals, LLC

Total testosterone IVD, kit, radioimmunoassay

• Primary Device ID: 00817830023211
• NIH Device Record Key: c091262f-acf8-4ac8-91a1-82dd1ec6b7ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MP Biomedicals LLC
• Version Model Number: 07189105
• Catalog Number: 07189105
• Company DUNS: 614875644
• Company Name: Mp Biomedicals, LLC
• 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	00817830023211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K791999

FDA Product Code

• CDZ: Radioimmunoassay, Testosterones And Dihydrotestosterone

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: 2023-08-11
• Device Publish Date: 2023-08-03

On-Brand Devices [MP Biomedicals LLC]

• 00817830023068: IMMUCHEM COATED TUBE 17ß-ESTRADIOL 125I RIA 500 TUBE KIT
• 00817830023051: IMMUCHEM COATED TUBE 17ß-ESTRADIOL 125I RIA 100 TUBE KIT
• 00817830023044: IMMUCHEM DOUBLE ANTIBODY 17ß-ESTRADIOL 125I RIA 500 TUBE KIT
• 00817830023037: IMMUCHEM DOUBLE ANTIBODY 17ß-ESTRADIOL 125I RIA 100 TUBE KIT
• 00817830023020: IMMUCHEM COATED TUBE DEHYDROEPIANDROSTERONE-SULFATE (DHEA-S) 125I RIA 100 TUBE KIT
• 00817830023013: IMMUCHEM DOUBLE ANTIBODY ANDROSTENEDIONE 125I RIA 100 TUBE KIT
• 00817830023204: IMMUCHEM DOUBLE ANTIBODY TESTOSTERONE 125I 100 TUBE KIT
• 00817830023198: IMMUCHEM COATED TUBE PROGESTERONE 125I RIA 500 TUBE KIT
• 00817830023181: IMMUCHEM COATED TUBE PROGESTERONE 125I RIA 100 TUBE KIT
• 00817830023174: IMMUCHEM DOUBLE ANTIBODY PROGESTERONE 125I RIA 500 TUBE KIT
• 00817830023167: IMMUCHEM DOUBLE ANTIBODY PROGESTERONE 125I RIA 100 TUBE KIT
• 00817830023150: IMUCHEM DOUBLE ANTIBODY 17α-HYDROXYPROGESTERONE 125I RIA 100 TUBE KIT
• 00817830023143: DOUBLE ANTIBODY GLUCAGON 125I 50 TUBE KIT
• 00817830023136: GASTRIN RIA 125I 200 TUBE KIT
• 00817830023129: NEONATAL GALACTOSE MW 10 PLATE ENZYME ASSAY KIT (WITH MEMBRANE)
• 00817830023112: NEONATAL GALACTOSE MW 10 PLATE ENZYME ASSAY KIT (WITHOUT MEMBRANE)
• 00817830023105: NEONATAL GALACTOSE MW 2 PLATE ENZYME ASSAY KIT (WITH MEMBRANE)
• 00817830023099: NEONATAL GALACTOSE MW 2 PLATE ENZYME ASSAY KIT (WITHOUT MEMBRANE)
• 00817830023082: IMMUCHEM DOUBLE ANTIBODY TOTAL ESTROGENS 125I RIA 500 TUBE KIT
• 00817830023075: IMMUCHEM DOUBLE ANTIBODY TOTAL ESTROGENS 125I RIA 100 TUBE KIT
• 00817830023006: GASTRIN RIA 125I 100 TUBE KIT
• 00817830023235: NEONATAL TRYPSIN MW 20 PLATE ELISA KIT
• 00817830023228: NEONATAL TRYPSIN MW 2 PLATE ELISA KIT
• 00817830023211: IMMUCHEM DOUBLE ANTIBODY TESTOSTERONE 125I 500 TUBE KIT