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R. HRT Pack 8 WELL

FDA UDI

Class II (US FDA UDI)

by Scimedx Corp.

Identity

Trade Name
R. HRT Pack 8 WELL FDA UDI
Generic Name
Striated muscle antibody IVD, kit, fluorescent immunoassay FDA UDI
Model / Reference
5428 FDA UDI

Identifiers

Catalog Number
5428 FDA UDI
Primary DI / UDI-DI
00813545020538 FDA UDI
FDA Product Code
DBL FDA UDI
GMDN Term
Striated muscle antibody IVD, kit, fluorescent immunoassay 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

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Striated muscle antibody IVD, kit, fluorescent immunoassay

R. HRT Pack 8 WELL by Scimedx Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Striated muscle antibody IVD, kit, fluorescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scimedx Corp.

Sources (1)

  • FDA UDI 0aafe8e3-e814-4f8b-b216-6fe977d07e5c 34 fields · synced May 30, 2026