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Digival

FDA UDI

by Alere Scarborough, Inc.

Identity

Trade Name
DIGIVAL FDA UDI
Generic Name
Photometric/spectroscopic immunoassay analyser IVD FDA UDI
Device Name
DIGIVAL is a small bench top instrument to be used in conjunction with Abbott™ rapid tests. FDA UDI
Model / Reference
EQ00600X FDA UDI
Description
DIGIVAL is a small bench top instrument to be used in conjunction with Abbott™ rapid tests. FDA UDI

Identifiers

Primary DI / UDI-DI
00811877010623 FDA UDI
510(k) Number
K162642 FDA UDI
GMDN Term
Photometric/spectroscopic immunoassay analyser IVD FDA UDI

Classification

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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Photometric/spectroscopic immunoassay analyser IVD

Digival by Alere Scarborough, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Photometric/spectroscopic immunoassay analyser IVD.

Cleared under the same submission

K162642 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alere Scarborough, Inc.

Sources (1)

  • FDA UDI 5ba2b0d8-d8da-4d9b-82c1-473df590f79a 34 fields · synced May 31, 2026