Identity
- Trade Name
- QUANTA Flash® DGP IgA Controls FDA UDI
- Generic Name
- Gliadin antibody IVD, control FDA UDI
- Device Name
- 1. QUANTA Flash DGP IgA Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives. 2. QUANTA Flash DGP IgA Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives. FDA UDI
- Model / Reference
- 701167 FDA UDI
- Description
- 1. QUANTA Flash DGP IgA Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives. 2. QUANTA Flash DGP IgA Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950557579 FDA UDI
- 510(k) Number
- K113863 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Gliadin antibody IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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: Gliadin antibody IVD, control
QUANTA Flash® DGP IgA Controls by Inova Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gliadin antibody IVD, control.
Cleared under the same submission
K113863 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 I | Pending data |
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Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (1)
- FDA UDI 536cfc9e-7813-47e8-99f6-a95a8a97adf4 36 fields · synced Jun 8, 2026