Identity
- Trade Name
- QUANTA Lite® β2GPI Screening ELISA FDA UDI
- Generic Name
- Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 1. 1x β2 GPI Screen ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted β2 GPI Decision Point 4. 1x 1.2mL prediluted β2 GPI Screening Control 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgGAM Conjugate, (goat), anti-human 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
- Model / Reference
- 708660 FDA UDI
- Description
- 1. 1x β2 GPI Screen ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted β2 GPI Decision Point 4. 1x 1.2mL prediluted β2 GPI Screening Control 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgGAM Conjugate, (goat), anti-human 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950454472 FDA UDI
- 510(k) Number
- K980230 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 Screening 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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- Autoimmune EIA — Bio-Rad Laboratories · Class II
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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 d99d2c40-7297-4ce7-8bcd-2097836c0cff 36 fields · synced May 30, 2026