Identity
- Trade Name
- QUANTA Flash® h-tTG IgG Reagents FDA UDI
- Generic Name
- Tissue transglutaminase antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- 1. 1 QUANTA Flash h-tTG IgG reagent cartridge 2. 1 Resuspension buffer 3. 1 Transfer pipet FDA UDI
- Model / Reference
- 701108 FDA UDI
- Description
- 1. 1 QUANTA Flash h-tTG IgG reagent cartridge 2. 1 Resuspension buffer 3. 1 Transfer pipet FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950544159 FDA UDI
- 510(k) Number
- K101644 FDA UDI
- FDA Product Code
- MVM FDA UDI
- GMDN Term
- Tissue transglutaminase antibody IVD, kit, chemiluminescent immunoassay 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, chemiluminescent immunoassay
QUANTA Flash® h-tTG IgG Reagents by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 96d16c18-069b-4db8-ae47-82b6ec5c7d78 36 fields · synced May 30, 2026