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Quanta Lite Ss-A 52 Elisa

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K063565

by Inova Diagnostics, Inc.

Identity

Trade Name
QUANTA Lite® SS-A 52 ELISA FDA UDI
Generic Name
Ro52 antibody (anti-Ro52)/Trim21 antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
1. 1x SS-A 52 ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ready to use ELISA Negative Control 3. 1x 1.2mL prediluted ready to use SS-A 52 ELISA Low Positive 4. 1x 1.2mL prediluted ready to use SS-A 52 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
704505 FDA UDI
Description
1. 1x SS-A 52 ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ready to use ELISA Negative Control 3. 1x 1.2mL prediluted ready to use SS-A 52 ELISA Low Positive 4. 1x 1.2mL prediluted ready to use SS-A 52 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
08426950544135 FDA UDI
510(k) Number
K063565 FDA 510(k)FDA UDI
FDA Product Code
OBE FDA 510(k)FDA UDI
GMDN Term
Ro52 antibody (anti-Ro52)/Trim21 antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 866.5100 FDA 510(k)
Regulation Number
866.5100 FDA 510(k)FDA UDI
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

Quanta Lite Ss-A 52 Elisa by Inova Diagnostics, Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Inova Diagnostics, Inc.

Sources (2)

  • FDA 510(k) K063565 24 fields · synced Jun 18, 2026
  • FDA UDI a3f01589-a395-493b-a6de-60aa5afe343e 36 fields · synced May 26, 2026