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QUANTA Lite® β2GPI IgG ELISA Bulk Pack

FDA UDI

Class II (US FDA UDI)

by Inova Diagnostics, Inc.

Identity

Trade Name
QUANTA Lite® β2GPI IgG ELISA Bulk Pack FDA UDI
Generic Name
Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder 2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgG ELISA Control 4. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator A 5. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator B 6. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator C 7. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator D 8. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator E 9. 9x 50mL HRP Sample Diluent 10. 10x 25mL HRP Wash Concentrate, 40x concentrate 11. 10x 10mL 2 HRP IgG Conjugate, (goat), anti-human IgG 12. 10x 10mL TMB Chromogen 13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
Model / Reference
708665.10 FDA UDI
Description
1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder 2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgG ELISA Control 4. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator A 5. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator B 6. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator C 7. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator D 8. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator E 9. 9x 50mL HRP Sample Diluent 10. 10x 25mL HRP Wash Concentrate, 40x concentrate 11. 10x 10mL 2 HRP IgG Conjugate, (goat), anti-human IgG 12. 10x 10mL TMB Chromogen 13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI

Identifiers

Primary DI / UDI-DI
08426950595816 FDA UDI
510(k) Number
K970551 FDA UDI
FDA Product Code
MSV FDA UDI
GMDN Term
Beta-2-glycoprotein I 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: Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)

QUANTA Lite® β2GPI 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 Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K970551 also covers:

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 68f53ff6-316d-48e4-baed-47b76d73e920 36 fields · synced May 31, 2026