What is FDA product code NTR?

MONOCLONAL OR POLYCLONAL ANTIBODY THAT RECOGNIZES THE HUMAN P63 PROTEIN IN THE NUCLEUS OF PROSTATIC BASAL CELLS USING ROUTINE IMMUNOHISTOCHEMICAL TECHNIQUES, INCLUDING HEAT-INDUCED ANTIGEN EPITOPE RETRIEVAL. THIS TEST IS INTENDED FOR LABORATORY USE TO QUALITATIVELY IDENTIFY THE P63 ANTIGEN IN HISTOLOGICAL SECTIONS FROM FORMALIN-FIXED PARAFFIN-EMBEDDED SAMPLES OF NORMAL AND/OR PATHOLOGICAL PROSTATE TISSUE OBTAINED BY NEEDLE BIOPSY OR SURGICAL PROCEDURES. THE PRESENCE OR ABSENCE OF P63 STAINING AIDS THE PATHOLOGIST IN THE DIFFERENTIAL DIAGNOSIS OF PROSTATE CANCER IN CONJUNCTION WITH MORPHOLOGICAL FINDINGS SEEN WITH HEMATOXYLIN AND EOSIN STAINING COMPLEMENTED BY PROPER CONTROLS.

Hematology › Biological StainsImmunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells

Portex

Name: Portex
Brand: Portex

5 catalogue numbers from 100/179/080, listed by ICU Medical, Inc, United States, under Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

5catalogue numbers in this listing

Who Else Makes It

Registered in Jilin.

Chinese manufacturers registered for FDA product code NTR
Manufacturer	City	Province	Registered as	Device types
Changchun LYZ Technology Co., Ltd.	Changchun	Jilin	Manufacturer	16

Record

Regulatory record for Portex
Listed by	ICU Medical, Inc, United States
FDA product code	NTR
Device type	Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells
Device class	Class 1
Regulation	21 CFR 864.1860
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K962175
Record published	2015-09-01
Record revised	2025-04-17 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Case of 12, box of 10, box of 2, case of 10

Catalogue Numbers

Catalogue numbers for Portex
Catalogue number	Size	Status
100/179/080		In distribution
100/179/090		In distribution
100/179/085		In distribution
100/529/100		In distribution
100/189/090		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Thermo Scientific	Richard-Allan Scientific LLC	37

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.