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MESACUP BP230 ELISA Kit

FDA UDI

Class II (US FDA UDI)

by Medical & Biological Laboratories Co., Ltd.

Identity

Trade Name
MESACUP BP230 ELISA Kit FDA UDI
Generic Name
Bullous pemphigoid antigen 1 (BPAG1) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The MESACUP BP230 ELISA kit is a semi-quantitative enzyme-linked immunosorvent assay (ELISA) for the detection of anti BP 230 antibodies in human serum. The MESACUP BP230 ELISA Kit is intended for in vitro diagnostic use as an aid in the diagnosis of bullous pemphgoid in conjunction with otehr laboratory and clinical findings. FDA UDI
Model / Reference
48 wells FDA UDI
Description
The MESACUP BP230 ELISA kit is a semi-quantitative enzyme-linked immunosorvent assay (ELISA) for the detection of anti BP 230 antibodies in human serum. The MESACUP BP230 ELISA Kit is intended for in vitro diagnostic use as an aid in the diagnosis of bullous pemphgoid in conjunction with otehr laboratory and clinical findings. FDA UDI

Identifiers

Catalog Number
7613US FDA UDI
Primary DI / UDI-DI
04987506015966 FDA UDI
FDA Product Code
OEG FDA UDI
GMDN Term
Bullous pemphigoid antigen 1 (BPAG1) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Bullous pemphigoid antigen 1 (BPAG1) antibody IVD, kit, enzyme immunoassay (EIA)

MESACUP BP230 ELISA Kit by Medical & Biological Laboratories Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bullous pemphigoid antigen 1 (BPAG1) antibody IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medical & Biological Laboratories Co., Ltd.

Sources (1)

  • FDA UDI b1b500eb-0911-41f2-93e1-40881131ad72 36 fields · synced May 31, 2026