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QUANTA Lite® GBM ELISA Bulk Pack

FDA UDI

Class II (US FDA UDI)

by Inova Diagnostics, Inc.

Identity

Trade Name
QUANTA Lite® GBM ELISA Bulk Pack FDA UDI
Generic Name
Glomerular basement membrane antibody (Goodpasture antibody) IVD, calibrator FDA UDI
Device Name
1. 10x GBM ELISA microwell plates (12-1 x 8 wells), with holder 2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted GBM ELISA Low Positive 4. 5x 1.2mL prediluted GBM ELISA High Positive 5. 9x 50mL HRP Sample Diluent 6. 10x 25mL HRP Wash Concentrate, 40x concentrate 7. 10x 10mL HS HRP IgG Conjugate, (goat), anti-human IgG 8. 10x 10mL TMB Chromogen 9. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid Additional Materials Required But Not Provided FDA UDI
Model / Reference
708740.10 FDA UDI
Description
1. 10x GBM ELISA microwell plates (12-1 x 8 wells), with holder 2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted GBM ELISA Low Positive 4. 5x 1.2mL prediluted GBM ELISA High Positive 5. 9x 50mL HRP Sample Diluent 6. 10x 25mL HRP Wash Concentrate, 40x concentrate 7. 10x 10mL HS HRP IgG Conjugate, (goat), anti-human IgG 8. 10x 10mL TMB Chromogen 9. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid Additional Materials Required But Not Provided FDA UDI

Identifiers

Primary DI / UDI-DI
08426950595823 FDA UDI
510(k) Number
K984336 FDA UDI
FDA Product Code
MVJ FDA UDI
GMDN Term
Glomerular basement membrane antibody (Goodpasture antibody) IVD, calibrator 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: Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, enzyme immunoassay (EIA)Glomerular basement membrane antibody (Goodpasture antibody) IVD, calibrator

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

Similar devices

Also classified as Glomerular basement membrane antibody (Goodpasture antibody) IVD, calibrator.

Cleared under the same submission

K984336 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 d5b70866-af18-4fd0-9175-a9f0affda967 36 fields · synced Jun 6, 2026