Identity
- Trade Name
- QuantideX qPCR BCR-ABL IS Kit FDA UDI
- Generic Name
- Philadelphia chromosome/BCR-ABL mRNA expression IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- 49574 FDA UDI
Identifiers
- Catalog Number
- 49574 FDA UDI
- Primary DI / UDI-DI
- 00863840000223 FDA UDI
- 510(k) Number
- DEN160003 FDA UDI
- FDA Product Code
- OYX FDA UDI
- GMDN Term
- Philadelphia chromosome/BCR-ABL mRNA expression IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.6060 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Philadelphia chromosome/BCR-ABL mRNA expression IVD, kit, nucleic acid technique (NAT)
QuantideX qPCR BCR-ABL IS Kit by Asuragen, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Philadelphia chromosome/BCR-ABL mRNA expression IVD, kit, nucleic acid technique (NAT).
- Xpert BCR-ABL Ultra — CEPHEID · Class II
- MRDx BCR-ABL Test — MOLECULARMD CORPORATION · Class II
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
- Asuragen, Inc.
Sources (1)
- FDA UDI 315259e2-f274-4af1-9a5a-0655ad80ef88 35 fields · synced Jun 8, 2026