Leica Biosystems HIGH TRANSM. ORANGE FOR LEICA DM

GUDID 00849832011446

Leica Biosystems HIGH TRANSM. ORANGE FOR LEICA DM

Leica Biosystems Richmond, Inc.

Fluorescence light microscope

• Primary Device ID: 00849832011446
• NIH Device Record Key: b40bc2da-ce68-409f-b65b-b9aa9466eca0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leica Biosystems HIGH TRANSM. ORANGE FOR LEICA DM
• Version Model Number: 232FLAL311972
• Company DUNS: 082930884
• Company Name: Leica Biosystems Richmond, 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: false
• 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

Customer Support Contacts

• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849832011446 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042542

FDA Product Code

• JOY: DEVICE, AUTOMATED CELL-LOCATING

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: 2017-07-14

Devices Manufactured by Leica Biosystems Richmond, Inc.

• 00849832020523 - Leica Biosystems: 2025-04-25 HistoCore SPECTRA H&E Staining System S1-800
• 00849832021247 - Leica Biosystems: 2025-04-25 HISTOCORE SPECTRA H&E STAINING SYSTEM S3
• 00849832021308 - Leica Biosystems: 2025-04-25 HISTOCORE SPECTRA H&E STAINING S3-800
• 00849832027034 - Leica Biosystems: 2025-04-25 HistoCore SPECTRA HE Staining System S2 800
• 00849832001294 - Leica Biosystems: 2025-04-23 IP ActivFlo Routine I, Taped, White
• 00849832001331 - Leica Biosystems: 2025-04-23 IP ActivFlo Biopsy II, Taped, White
• 00849832001348 - Leica Biosystems: 2025-04-23 IP ActivFlo Biopsy III, Taped, White
• 00849832001355 - Leica Biosystems: 2025-04-23 IP ActivFlo Biopsy III, Taped, Blue