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Rabbit Monoclonal Anti-Human ROS1 Antibody, EP282

FDA UDI

Class I (US FDA UDI)

by Epitomics, Inc.

Identity

Trade Name
Rabbit Monoclonal Anti-Human ROS1 Antibody, EP282 FDA UDI
Generic Name
Proto-oncogene tyrosine-protein kinase ROS (ROS1) IVD, antibody FDA UDI
Device Name
Rabbit Monoclonal Anti-Human ROS1 (282), 0.5 mL concentrated FDA UDI
Model / Reference
AC-0271B FDA UDI
Description
Rabbit Monoclonal Anti-Human ROS1 (282), 0.5 mL concentrated FDA UDI

Identifiers

Primary DI / UDI-DI
00810113067230 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Proto-oncogene tyrosine-protein kinase ROS (ROS1) IVD, antibody FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4020 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

No

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Total Volume — 0.5 Milliliter FDA UDI

Category: Proto-oncogene tyrosine-protein kinase ROS (ROS1) IVD, antibody

Rabbit Monoclonal Anti-Human ROS1 Antibody, EP282 by Epitomics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Proto-oncogene tyrosine-protein kinase ROS (ROS1) IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Epitomics, Inc.

Sources (1)

  • FDA UDI f5728953-3daf-496d-ae1e-5e7e44f68bc0 36 fields · synced May 30, 2026