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QUANTA Flash® DGP Screen Controls

FDA UDI

Class I (US FDA UDI)

by Inova Diagnostics, Inc.

Identity

Trade Name
QUANTA Flash® DGP Screen Controls FDA UDI
Generic Name
Gliadin antibody IVD, control FDA UDI
Device Name
1. QUANTA Flash DGP Screen Negative Control: Two (2) barcode labeled tubes with buffer containing human serum antibodies to DGP, prediluted, ready to use, 0.5mL (containing buffer, protein stabilizers, and preservatives). 2. QUANTA Flash DGP Screen Positive Control: Two (2) barcode labeled tubes with buffer containing human serum antibodies to DGP, prediluted, ready to use, 0.5mL (containing buffer, protein stabilizers, and preservatives). FDA UDI
Model / Reference
701112 FDA UDI
Description
1. QUANTA Flash DGP Screen Negative Control: Two (2) barcode labeled tubes with buffer containing human serum antibodies to DGP, prediluted, ready to use, 0.5mL (containing buffer, protein stabilizers, and preservatives). 2. QUANTA Flash DGP Screen Positive Control: Two (2) barcode labeled tubes with buffer containing human serum antibodies to DGP, prediluted, ready to use, 0.5mL (containing buffer, protein stabilizers, and preservatives). FDA UDI

Identifiers

Primary DI / UDI-DI
08426950595847 FDA UDI
510(k) Number
K111414 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Gliadin antibody IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 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, control

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

Similar devices

Also classified as Gliadin antibody IVD, control.

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 63f15581-f71d-462a-8c30-b8dac816eaac 36 fields · synced May 29, 2026