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QUANTA Lite® ssDNA ELISA

FDA UDI

Class II (US FDA UDI)

by Inova Diagnostics, Inc.

Identity

Trade Name
QUANTA Lite® ssDNA ELISA FDA UDI
Generic Name
Single stranded DNA antibody (anti-ssDNA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
1. 1x ssDNA ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ssDNA ELISA Low Positive 4. 1 x1.2mL prediluted ssDNA ELISA High Positive 5. 1 x50mL HRP Sample Diluent 6. 1 x25mL 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
708525 FDA UDI
Description
1. 1x ssDNA ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ssDNA ELISA Low Positive 4. 1 x1.2mL prediluted ssDNA ELISA High Positive 5. 1 x50mL HRP Sample Diluent 6. 1 x25mL 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
08426950593744 FDA UDI
FDA Product Code
LJM FDA UDI
GMDN Term
Single stranded DNA antibody (anti-ssDNA) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5100 FDA UDI
Commercial Distribution
Not 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

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

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 842884f8-a0a6-4173-9d07-ee41f68ff049 36 fields · synced Jun 8, 2026