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QUANTA Lite® ASCA IgG ELISA

FDA UDI

Class II (US FDA UDI)

by Inova Diagnostics, Inc.

Identity

Trade Name
QUANTA Lite® ASCA IgG ELISA FDA UDI
Generic Name
Saccharomyces cerevisiae immunoglobulin G (IgG) antibody IVD, kit enzyme immunoassay (EIA) FDA UDI
Device Name
(S. cerevisiae) 1. 1x ASCA IgG ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ASCA IgG ELISA Low Positive 4. 1x 1.2mL prediluted ASCA IgG ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
Model / Reference
708865 FDA UDI
Description
(S. cerevisiae) 1. 1x ASCA IgG ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ASCA IgG ELISA Low Positive 4. 1x 1.2mL prediluted ASCA IgG ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI

Identifiers

Primary DI / UDI-DI
08426950514206 FDA UDI
510(k) Number
DEN000007 FDA UDI
FDA Product Code
NBT FDA UDI
GMDN Term
Saccharomyces cerevisiae immunoglobulin G (IgG) antibody IVD, kit enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5785 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: Saccharomyces cerevisiae immunoglobulin G (IgG) antibody IVD, kit enzyme immunoassay (EIA)

QUANTA Lite® ASCA IgG ELISA by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Saccharomyces cerevisiae immunoglobulin G (IgG) 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 707d3112-38d6-4ec3-92d5-78d450c936e9 36 fields · synced May 30, 2026