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QUANTA Flash® DGP Screen Calibrators

FDA UDI

Class II (US FDA UDI)

by Inova Diagnostics, Inc.

Identity

Trade Name
QUANTA Flash® DGP Screen Calibrators FDA UDI
Generic Name
Gliadin antibody IVD, calibrator FDA UDI
Device Name
1. QUANTA Flash DGP Screen Calibrator 1: Two (2) barcode labeled tubes with buffer containing human serum antibodies to DGP, prediluted, ready to use, 0.3mL (containing buffer, protein stabilizers, and preservatives). 2. QUANTA Flash DGP Screen Calibrator 2: Two (2) barcode labeled tubes with buffer containing human serum antibodies to DGP, prediluted, ready to use, 0.3mL (containing buffer, protein stabilizers, and preservatives). FDA UDI
Model / Reference
701111 FDA UDI
Description
1. QUANTA Flash DGP Screen Calibrator 1: Two (2) barcode labeled tubes with buffer containing human serum antibodies to DGP, prediluted, ready to use, 0.3mL (containing buffer, protein stabilizers, and preservatives). 2. QUANTA Flash DGP Screen Calibrator 2: Two (2) barcode labeled tubes with buffer containing human serum antibodies to DGP, prediluted, ready to use, 0.3mL (containing buffer, protein stabilizers, and preservatives). FDA UDI

Identifiers

Primary DI / UDI-DI
08426950595830 FDA UDI
510(k) Number
K111414 FDA UDI
FDA Product Code
JIX FDA UDI
GMDN Term
Gliadin antibody IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1150 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

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Gliadin antibody IVD, calibrator

QUANTA Flash® DGP Screen Calibrators by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gliadin antibody IVD, calibrator.

Cleared under the same submission

K111414 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Inova Diagnostics, Inc.

Sources (1)

  • FDA UDI 067b1469-3f2b-418f-a0ba-e6dee0662a89 36 fields · synced May 30, 2026