Identity
- Trade Name
- QUANTA Flash® Centromere Controls FDA UDI
- Generic Name
- Centromere antibody IVD, control FDA UDI
- Device Name
- 1. QUANTA Flash Centromere Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to centromere in buffer, stabilizers, and preservatives. 2. QUANTA Flash Centromere Positive Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to centromere in buffer, stabilizers, and preservatives. FDA UDI
- Model / Reference
- 701197 FDA UDI
- Description
- 1. QUANTA Flash Centromere Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to centromere in buffer, stabilizers, and preservatives. 2. QUANTA Flash Centromere Positive Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to centromere in buffer, stabilizers, and preservatives. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950596097 FDA UDI
- 510(k) Number
- K123880 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Centromere 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: Centromere antibody IVD, control
QUANTA Flash® Centromere Controls by Inova Diagnostics, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (1)
- FDA UDI 67a16228-d026-4874-a3cb-b8c1f0b310fe 36 fields · synced May 30, 2026