Identity
- Trade Name
- QUANTA Lite® β2GPI IgG ELISA FDA UDI
- Generic Name
- Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted 2 GPI IgG ELISA Control 4. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator A 5. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator B 6. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator C 7. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator D 8. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator E 9. 1x 50mL HRP Sample Diluent 10. 1x 25mL HRP Wash Concentrate, 40x concentrate 11. 1x 10mL 2 HRP IgG Conjugate, (goat), anti-human IgG 12. 1x 10mL TMB Chromogen 13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
- Model / Reference
- 708665 FDA UDI
- Description
- 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted 2 GPI IgG ELISA Control 4. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator A 5. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator B 6. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator C 7. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator D 8. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator E 9. 1x 50mL HRP Sample Diluent 10. 1x 25mL HRP Wash Concentrate, 40x concentrate 11. 1x 10mL 2 HRP IgG Conjugate, (goat), anti-human IgG 12. 1x 10mL TMB Chromogen 13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950451112 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 by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA).
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- LAPL™ aB2GPI IgA HRP ELISA Kit — LOUISVILLE APL DIAGNOSTICS, INC.
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc. · Class II
- Autoimmune EIA — Bio-Rad Laboratories · Class II
- Autoimmune EIA — Bio-Rad Laboratories · Class II
- QUANTA Lite® β2GPI IgA ELISA Bulk Pack — INOVA DIAGNOSTICS, INC. · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (1)
- FDA UDI b92c8aeb-79e4-40d4-b61f-b1b1f7a8d92b 36 fields · synced Jun 1, 2026