Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003155207

FEI Number

3003155207

Entity Name

MEDICAL & BIOLOGICAL LABORATORIES CO., LTD. Ina Laboratory

City/State/Country

INA Nagano, JP

Establishment Address

1018-1 Terasawaoka, INA Nagano 396-0002, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MEDICAL & BIOLOGICAL LABORATORIES CO., LTD. Ina Laboratory (Owner Number: 9039476)

Owner / Operator Contact Address

SUMITOMO FUDOSAN SHIBADAIMON NICHOME BLDG., 2-11-8 Shibadaimon, Minato-ku, JP-13 105-0012, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K071961

PMA Number

N/A

All Registered Proprietary Names

MESACUP BP180 ELISA Kit and MESACUP BP230 ELISA Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OEG	Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230	Immunology	Class 2	866.5660	2008-12-16

Official Correspondent

No official correspondent registered.

US Agent Details

Marti Shapiro Email: mbsk65@gmail.com Phone: (562) 4801558

Related Public Records

Same Entity

MEDICAL & BIOLOGICAL LABORATORIES CO., LTD. Ina Laboratory

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003155207. Last updated year: 2026. Please use registration number 3003155207 when referencing this establishment in official correspondence.