← Back to catalogue

ProSpecT Shiga Toxin E. coli (STEC) Microplate Assay

FDA UDI

Class I (US FDA UDI)

by Remel Europe Limited

Identity

Trade Name
ProSpecT Shiga Toxin E. coli (STEC) Microplate Assay FDA UDI
Generic Name
Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Model / Reference
R2474096 FDA UDI

Identifiers

Primary DI / UDI-DI
05056080501673 FDA UDI
510(k) Number
K980507 FDA UDI
FDA Product Code
GMZ FDA UDI
GMDN Term
Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3255 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

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: Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA)

ProSpecT Shiga Toxin E. coli (STEC) Microplate Assay by Remel Europe Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K980507 also covers:

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
Remel Europe Limited

Sources (1)

  • FDA UDI 564d7db0-c06d-4ba4-9f5a-23e3e4282bea 34 fields · synced Jun 1, 2026