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Herpes Simplex Virus Antigen Control Slide, 4 wells
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Herpes Simplex Virus Antigen Control Slide, 4 wells FDA UDI
- Generic Name
- Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, control FDA UDI
- Model / Reference
- QHS-3504 FDA UDI
Identifiers
- Catalog Number
- QHS-3504 FDA UDI
- Primary DI / UDI-DI
- B110QHS35040 FDA UDI
- 510(k) Number
- K890616 FDA UDI
- FDA Product Code
- LJG FDA UDI
- GMDN Term
- Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2660 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, control
Herpes Simplex Virus Antigen Control Slide, 4 wells by Bion Enterprises, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, control.
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- D3 — DIAGNOSTIC HYBRIDS, INC. · Class II
- D3 — DIAGNOSTIC HYBRIDS, INC. · Class II
- Herpes Simplex Virus I & II Control Slides — BIO SB, INC. · Class I
- D3 — DIAGNOSTIC HYBRIDS, INC. · Class I
- Herpes Simplex Virus II Control Slides — BIO SB, INC. · Class I
Cleared under the same submission
K890616 also covers:
- Adenovirus Antigen Control Slide, 2 wells — BION ENTERPRISES, LTD.
- Chlamydia Antigen Contol Slide (Elem. Bodies), 2 wells — BION ENTERPRISES, LTD.
- Cytomegalovirus Antigen Control Slide, 2 wells — BION ENTERPRISES, LTD.
- Enterovirus Panel Antigen Control Slide, 4 wells — BION ENTERPRISES, LTD.
- Influenza A & B Virus Antigen Control Slide, 4 wells — BION ENTERPRISES, LTD.
- Measles (Rubeola) Antigen Control Slide, 2 wells — BION ENTERPRISES, LTD.
- Mumps Antigen Control Slide, 2 wells — BION ENTERPRISES, LTD.
- Parainfluenza Virus Antigen Control Slide, 6 wells — BION ENTERPRISES, LTD.
- Respiratory Syncytial Virus Antigen Control Slide, 2 wells — BION ENTERPRISES, LTD.
- Varicella Zoster Virus Antigen Control Slide, 2 wells — BION ENTERPRISES, LTD.
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
- Bion Enterprises, Ltd.
Sources (1)
- FDA UDI 0df74411-72c7-42df-9231-954deb7135b7 36 fields · synced Jun 8, 2026