← Back to catalogue

QUANTA Lite® F-Actin IgA ELISA

FDA UDI

Class II (US FDA UDI)

by Inova Diagnostics, Inc.

Identity

Trade Name
QUANTA Lite® F-Actin IgA ELISA FDA UDI
Generic Name
F-Actin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
1. 1x F-Actin ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted F-Actin IgA ELISA Low Positive 4. 1 x1.2mL prediluted F-Actin IgA ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgA Conjugate, (goat), anti -human IgA 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
Model / Reference
704500 FDA UDI
Description
1. 1x F-Actin ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted F-Actin IgA ELISA Low Positive 4. 1 x1.2mL prediluted F-Actin IgA ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgA Conjugate, (goat), anti -human IgA 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI

Identifiers

Primary DI / UDI-DI
08426950594093 FDA UDI
510(k) Number
K072967 FDA UDI
FDA Product Code
MVM FDA UDI
GMDN Term
F-Actin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5660 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: F-Actin antibody IVD, kit, enzyme immunoassay (EIA)

QUANTA Lite® F-Actin IgA ELISA by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as F-Actin antibody IVD, kit, enzyme immunoassay (EIA).

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
Inova Diagnostics, Inc.

Sources (1)

  • FDA UDI bb766f75-dd02-420b-82c9-e6da1cb67523 36 fields · synced May 30, 2026