Identity
- Trade Name
- QUANTA Lite® h-tTG IgG ELISA FDA UDI
- Generic Name
- Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- (Human Tissue Transglutaminase) 1. 1x ANA ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ANA ELISA Low Positive 4. 1x 1.2mL prediluted ANA ELISA High Positive 5. 1x 50mL ANA Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HS 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
- 708755 FDA UDI
- Description
- (Human Tissue Transglutaminase) 1. 1x ANA ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ANA ELISA Low Positive 4. 1x 1.2mL prediluted ANA ELISA High Positive 5. 1x 50mL ANA Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HS 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
- 08426950456131 FDA UDI
- 510(k) Number
- K011570 FDA UDI
- FDA Product Code
- MVM FDA UDI
- GMDN Term
- Tissue transglutaminase 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: Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)
QUANTA Lite® h-tTG IgG ELISA by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA).
- AESKULISA tTg-G New Generation — Aesku.Diagnostics GmbH & Co. KG · Class II
- Autoimmune EIA — Bio-Rad Laboratories · Class II
- Anti Tissue Transglutaminase-G (Anti-tTG-G) ELISA — American Laboratory Products Company · Class II
- Anti-tissue Transglutaminase ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AG · Class II
- Anti Tissue Transglutaminase-A (Anti-tTg-A) ELISA — American Laboratory Products Company · Class II
- Eu-tTG IgA — Eurospital · Class II
- EL-tTG IgA/IgG — THERATEST LABORATORIES, INC.
- AESKULISA tTg-G New Generation — Aesku.Diagnostics GmbH & Co. KG · Class II
Cleared under the same submission
K011570 also covers:
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 60f49384-d94a-4b4f-8258-897828cb0b63 36 fields · synced May 30, 2026