Identity
- Trade Name
- ROX 1000 Size Ladder FDA UDI
- Generic Name
- Nucleic acid hybridization detection IVD, control FDA UDI
- Device Name
- General Purpose Reagent FDA UDI
- Model / Reference
- A00058 FDA UDI
- Description
- General Purpose Reagent FDA UDI
Identifiers
- Catalog Number
- A00058 FDA UDI
- Primary DI / UDI-DI
- 00850017493087 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Nucleic acid hybridization detection IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nucleic acid hybridization detection IVD, control
ROX 1000 Size Ladder by Asuragen, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nucleic acid hybridization detection IVD, control.
- RISH™ RNA Positive Control Probe — BIOCARE MEDICAL, LLC · Class I
- ISH NEGATIVE CONTROL — Ventana Medical Systems · Class I
- ALU POSITIVE CONTROL PROBE II — Ventana Medical Systems · Class I
- RISH™ RNA Negative Control Probe — BIOCARE MEDICAL, LLC · Class I
- BOND — Leica Biosystems Newcastle, Limited · Class I
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
- HER2 Dual ISH 3-in-1 Xenograft Slides — Ventana Medical Systems · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Asuragen, Inc.
Sources (1)
- FDA UDI 9dfec55a-c324-418b-97c8-3beea10a33ff 35 fields · synced May 30, 2026