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QUANTA LITE® R h-tTG IgG ELISA Bulk Pack (Lab Corp)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- QUANTA LITE® R h-tTG IgG ELISA Bulk Pack (Lab Corp) FDA UDI
- Generic Name
- Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 1. Instruction leaflet: Giving full assay details. 2. QC Certificate: Indicating the expected performance of the batch. 3. Human Transglutaminase Coated Wells: 12 breakapart 8 well strips coated with recombinant tTG. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches. 4. HRP Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored pink, 5. HRP Wash Concentrate: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells. 6. R h-tTG IgG Calibrators: 5 bottles, each containing 1.2mL of diluted human serum, with the following concentrations of anti-tTG IgG autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. 7. R h-tTG IgG Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. 8. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. 9. HRP R h-tTG IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Colored blue. 10. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. 11. Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric Acid. FDA UDI
- Model / Reference
- 704610.10L FDA UDI
- Description
- 1. Instruction leaflet: Giving full assay details. 2. QC Certificate: Indicating the expected performance of the batch. 3. Human Transglutaminase Coated Wells: 12 breakapart 8 well strips coated with recombinant tTG. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches. 4. HRP Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored pink, 5. HRP Wash Concentrate: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells. 6. R h-tTG IgG Calibrators: 5 bottles, each containing 1.2mL of diluted human serum, with the following concentrations of anti-tTG IgG autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. 7. R h-tTG IgG Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. 8. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. 9. HRP R h-tTG IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Colored blue. 10. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. 11. Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric Acid. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950593928 FDA UDI
- 510(k) Number
- K040466 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® R h-tTG IgG ELISA Bulk Pack (Lab Corp) 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
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- 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
K040466 also covers:
- QUANTA LITE® R h-tTG IgA ELISA Kit, Bulk (Lab Corp) — INOVA DIAGNOSTICS, INC.
- QUANTA Lite® R h-tTG IgA ELISA — INOVA DIAGNOSTICS, INC.
- QUANTA Lite® R h-tTG IgA ELISA Bulk Pack — INOVA DIAGNOSTICS, INC.
- QUANTA Lite® R h-tTG IgG ELISA — INOVA DIAGNOSTICS, INC.
- QUANTA Lite® R h-tTG IgG ELISA Bulk Pack — INOVA DIAGNOSTICS, INC.
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 7fa94f7a-4953-4d6f-95b6-d6d10d3cb49c 36 fields · synced Jun 1, 2026