- Physicians Office Resource

ANTI-NAPSIN A - AM701-5M

Device Description

One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of napsin A in a clinical specimen.

Environmental Conditions

Special Storage Condition, Specify

Store at 2-8°C

Device Sizes

Total Volume: 6 Milliliter

Total Volume: 6 Milliliter

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: NJT

Device Name: Immunohistochemistry Reagents And Kits

Device Class: 1

Physical State: N/A

Definition: according to the regs..."..used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin.

Submission Type ID: 4

Review Panel: PA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 864.1860

Third Party Flag: N

Medical Specialty: HE

Device Identifiers

Device Id: 00810119670557

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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