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NeoPATH Pro Universal AP Polymer Kit

FDA UDI

Class I (US FDA UDI)

by Biocare Medical, Llc

Identity

Trade Name
NeoPATH Pro Universal AP Polymer Kit FDA UDI
Generic Name
Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry FDA UDI
Model / Reference
NPRI10027KT135 FDA UDI

Identifiers

Primary DI / UDI-DI
00847627038951 FDA UDI
FDA Product Code
PPM FDA UDI
GMDN Term
Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

NeoPATH Pro Universal AP Polymer Kit by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biocare Medical, Llc

Sources (1)

  • FDA UDI 8db0ffbd-84dd-42de-852a-11e1d6d72f7a 33 fields · synced May 31, 2026