BOND™ PA0064

GUDID 05055331326485

Napsin A (IP64) antibody is intended to be used for the qualitative identification by light microscopy of napsin A molecules in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).

LEICA BIOSYSTEMS NEWCASTLE LTD

Napsin A IVD, antibody

• Primary Device ID: 05055331326485
• NIH Device Record Key: 6d3d5cb9-6957-4362-b2f3-46311f57e042
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOND™
• Version Model Number: PA0064
• Catalog Number: PA0064
• Company DUNS: 397134693
• Company Name: LEICA BIOSYSTEMS NEWCASTLE LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055331326485 [Primary]

FDA Product Code

• NJT: Immunohistochemistry Reagents And Kits

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: 2021-03-29
• Device Publish Date: 2021-03-19

On-Brand Devices [BOND™]

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• 05055331325655: CD31 (JC70A) monoclonal antibody is intended to be used for the qualitative identification by li
• 05055331318053: Ki67 (K2) monoclonal antibody is intended to be used for the qualitative identification by light
• 05055331311009: The BOND Aspirating Probe Cleaning System is intended for automated cleaning of aspirating probe
• 05055331304780: Carcinoembryonic Antigen (II-7) monoclonal antibody is intended to be used for the qualitative i
• 05055331304773: Prostatic Acid Phosphatase (PASE/4LJ) monoclonal antibody is intended to be used for the qualita
• 05055331304766: Human Chorionic Gonadotrophin (Polyclonal) antibody is intended to be used for the qualitative i
• 05055331304612: Bcl-2 (bcl-2/100/D5) monoclonal antibody is intended to be used for the qualitative identificati
• 05055331304599: Cytokeratin HMW (34BE12) monoclonal antibody is intended to be used for the qualitative identifi
• 05055331304582: CD45RO (UCHL1) monoclonal antibody is intended to be used for the qualitative identification by
• 05055331304544: CD5 (4C7) monoclonal antibody is intended to be used for the qualitative identification by light
• 05055331304513: CD8 (4B11) monoclonal antibody is intended to be used for the qualitative identification by ligh
• 05055331304469: DOG-1 (K9) monoclonal antibody is intended to be used for the qualitative identification by ligh
• 05055331304438: CD1a (MTB1) monoclonal antibody is intended to be used for the qualitative identification by lig
• 05055331304421: CD22 (FPC1) monoclonal antibody is intended to be used for the qualitative identification by lig
• 05055331304377: CD2 (11F11) monoclonal antibody is intended to be used for the qualitative identification by lig
• 05055331304360: CD68 (514H12) monoclonal antibody is intended to be used for the qualitative identification by l
• 05055331304322: CD25 (4C9) monoclonal antibody is intended to be used for the qualitative identification by ligh
• 05055331304254: Calretinin (CAL6) monoclonal antibody is intended to be used for the qualitative identification
• 05055331304179: von Willebrand Factor (36B11) monoclonal antibody is intended to be used for the qualitative ide
• 05055331304070: Cytokeratin 5 (XM26) monoclonal antibody is intended to be used for the qualitative identificati
• 05055331304049: Myosin Heavy Chain (smooth muscle) (S131) monoclonal antibody is intended to be used for the qua
• 05055331303943: Wilms’ Tumor (WT49) monoclonal antibody is intended to be used for the qualitative identificat
• 05055331303783: CD20 (MJ1) monoclonal antibody is intended to be used for the qualitative identification by ligh
• 05055331326829: CD15 (MMA) monoclonal antibody is intended to be used for the qualitative identification by ligh
• 05055331326812: Carcinoembryonic Antigen (CD66e) (COL-1) monoclonal antibody is intended to be used for the qual
• 05055331326492: Alpha-Methylacyl-CoA Racemase (EPMU1) antibody is intended to be used for the qualitative identi
• 05055331326485: Napsin A (IP64) antibody is intended to be used for the qualitative identification by light micr
• 05055331325907: Chromogranin A (5H7) monoclonal antibody is intended to be used for the qualitative identificati
• 05055331325600: CD163 (10D6) monoclonal antibody is intended to be used for the qualitative identification by li
• 05055331325211: CDX2 (EP25) monoclonal antibody is intended to be used for the qualitative identification by lig
• 05055331322524: Melanoma Marker (HMB45) monoclonal antibody is intended to be used for the qualitative identific
• 05055331322494: Melan A (A103) monoclonal antibody is intended to be used for the qualitative identification by
• 05055331321596: Vimentin (V9) monoclonal antibody is intended to be used for the qualitative identification by l
• 05055331321565: p63 (7JUL) monoclonal antibody is intended to be used for the qualitative identification by ligh
• 05055331320414: Cytokeratin 7 (RN7) monoclonal antibody is intended to be used for the qualitative identificatio
• 05055331319104: Melanoma Marker (HMB45) monoclonal antibody is intended to be used for the qualitative identific
• 05055331318077: Immunoglobulin M (8H6) monoclonal antibody is intended to be used for the qualitative identifica
• 05055331318039: Beta-Catenin (17C2) monoclonal antibody is intended to be used for the qualitative identificatio
• 05055331318022: Cytokeratin 17 (E3) monoclonal antibody is intended to be used for the qualitative identificatio
• 05055331304728: Desmin (DE-R-11) monoclonal antibody is intended to be used for the qualitative identification b
• 05055331304681: CD45 (X16/99) monoclonal antibody is intended to be used for the qualitative identification by l
• 05055331304667: p53 (DO-7) monoclonal antibody is intended to be used for the qualitative identification by ligh
• 05055331304445: Melan A (A103) monoclonal antibody is intended to be used for the qualitative identification by
• 05055331304308: CD61 (2f2) monoclonal antibody is intended to be used for the qualitative identification by ligh