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QUANTA Lite® Actin IgG ELISA Bulk Pack

FDA UDI

Class II (US FDA UDI)

by Inova Diagnostics, Inc.

Identity

Trade Name
QUANTA Lite® Actin IgG ELISA Bulk Pack FDA UDI
Generic Name
F-Actin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
1. 10x Actin IgG ELISA microwell plates (12-1 x 8 wells), with holder 2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted Actin IgG ELISA Low Positive 4. 5x 1.2mL prediluted Actin IgG ELISA High Positive 5. 9x 50mL HRP Sample Diluent 6. 10x 25mL HRP Wash Concentrate, 40x concentrate 7. 10x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 10x 10mL TMB Chromogen 9. 10 x10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
Model / Reference
708785.10 FDA UDI
Description
1. 10x Actin IgG ELISA microwell plates (12-1 x 8 wells), with holder 2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted Actin IgG ELISA Low Positive 4. 5x 1.2mL prediluted Actin IgG ELISA High Positive 5. 9x 50mL HRP Sample Diluent 6. 10x 25mL HRP Wash Concentrate, 40x concentrate 7. 10x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 10x 10mL TMB Chromogen 9. 10 x10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI

Identifiers

Primary DI / UDI-DI
08426950594697 FDA UDI
510(k) Number
K021648 FDA UDI
FDA Product Code
NJF FDA UDI
GMDN Term
F-Actin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5120 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® Actin IgG ELISA Bulk Pack 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

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Manufacturer

Manufacturer
Inova Diagnostics, Inc.

Sources (1)

  • FDA UDI 79c9a97b-9188-4717-8b5a-5c7a19402432 36 fields · synced May 30, 2026