SEPTA, 96 WELL CE-IVD 3500 

GUDID 10190302000260

LIFE TECHNOLOGIES CORPORATION

Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent Nucleic acid hybridization detection IVD, reagent

• Primary Device ID: 10190302000260
• NIH Device Record Key: d38cd25f-bd82-4f7d-be3f-f0a7c957b9a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SEPTA, 96 WELL CE-IVD 3500
• Version Model Number: 4410700
• Company DUNS: 182158873
• Company Name: LIFE TECHNOLOGIES CORPORATION
• Device Count: 20
• 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: false
• 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	10190302000260 [Primary]
GS1	80190302000269 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• BK110039

FDA Product Code

• PCA: DNA genetic analyzer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-08-01

Devices Manufactured by LIFE TECHNOLOGIES CORPORATION

• 10190302010320 - Human CD138 R-PE Conjugate: 2023-11-30
• 10190302010337 - Human CD138 PE-Cy®5.5 Conjugate: 2023-11-30
• 10190302011730 - Human CD61 APC Conjugate: 2023-11-30
• 10190302000680 - 3500Dx Series Polymer Pouch Caps: 2023-11-20
• 10190302000116 - Histostain® Plus Broad Spectrum: 2023-10-18
• 10190302000123 - invitrogen: 2023-10-18
• 10190302000130 - invitrogen: 2023-10-18
• 10190302008242 - Histostain® Plus 3rd Gen IHC Detection Kit (1000 Slides): 2023-10-18