← Back to catalogue

P. EDL Pack 8 WELL

FDA UDI

Class II (US FDA UDI)

by Scimedx Corp.

Identity

Trade Name
P. EDL Pack 8 WELL FDA UDI
Generic Name
Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay FDA UDI
Model / Reference
5308E FDA UDI

Identifiers

Catalog Number
5308E FDA UDI
Primary DI / UDI-DI
00813545022754 FDA UDI
FDA Product Code
MVM FDA UDI
GMDN Term
Endomysium antibody (EMA) 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: Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay

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

Similar devices

Also classified as Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Scimedx Corp.

Sources (1)

  • FDA UDI 971f1a4e-ce18-4ece-849f-8eedbac8986d 34 fields · synced Jun 8, 2026