Identity
- Trade Name
- BioPlex 2200 FDA UDI
- Generic Name
- Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, control FDA UDI
- Device Name
- HSV-1 & HSV-2 Control Lot Data FDA UDI
- Model / Reference
- 6633340 FDA UDI
- Description
- HSV-1 & HSV-2 Control Lot Data FDA UDI
Identifiers
- Catalog Number
- 6633340 FDA UDI
- Primary DI / UDI-DI
- 00847865000932 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) 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
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
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: Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, control
BioPlex 2200 by Bio-Rad Laboratories — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, control.
- PreciControl HSV — Roche Diagnostics Corp. · Class I
- HSV Serum Panel — DiaSorin Molecular LLC · Class II
- Herpes Simplex Negative Control — BION ENTERPRISES, LTD. · Class II
- Herpes Simplex IgG Control — BION ENTERPRISES, LTD. · Class II
- BioPlex 2200 — Bio-Rad Laboratories · 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 |
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Manufacturer
- Manufacturer
- Bio-Rad Laboratories
Sources (1)
- FDA UDI cdf07731-4534-41bd-81d4-48fc5beb9080 36 fields · synced May 30, 2026