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Universal Disc Cover Tape

FDA UDI

Class II (US FDA UDI)

by DiaSorin Molecular LLC

Identity

Trade Name
Universal Disc Cover Tape FDA UDI
Generic Name
Assay adhesive sealing/fixation film IVD FDA UDI
Model / Reference
MOL1500 FDA UDI

Identifiers

Catalog Number
MOL1500 FDA UDI
Primary DI / UDI-DI
10816101025111 FDA UDI
510(k) Number
K102314 FDA UDI
FDA Product Code
OOI FDA UDI
GMDN Term
Assay adhesive sealing/fixation film IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.2570 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

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Assay adhesive sealing/fixation film IVD

Universal Disc Cover Tape by DiaSorin Molecular LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Assay adhesive sealing/fixation film IVD.

Cleared under the same submission

K102314 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DiaSorin Molecular LLC

Sources (1)

  • FDA UDI 31b1eeff-1812-478c-ab6c-f09ef6641639 36 fields · synced Jun 9, 2026