Identity
- Trade Name
- ZYMUTEST HIA MonoStrip IgG FDA UDI
- Generic Name
- Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- RK041A FDA UDI
Identifiers
- Catalog Number
- RK041A FDA UDI
- Primary DI / UDI-DI
- 03663537046803 FDA UDI
- 510(k) Number
- K071255 FDA UDI
- FDA Product Code
- LCO FDA UDI
- GMDN Term
- Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7695 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)
ZYMUTEST HIA MonoStrip IgG by Hyphen Biomed — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA).
- EliA IgG Conjugate — Phadia GmbH · Class II
- ImmunoCAP Specific IgG Curve Controls — Phadia GmbH · Class I
- EliA IgG Calibrators — Phadia GmbH · Class II
- EliA IgG Curve Control — Phadia GmbH · Class II
- ImmunoCAP Specific IgG Calibrators — Phadia GmbH · Class I
- ImmunoCAP Specific IgG Conjugate — Phadia GmbH · Class I
- ZYMUTEST HIA IgG — HYPHEN BIOMED · Class II
Cleared under the same submission
K071255 also covers:
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
- Hyphen Biomed
Sources (1)
- FDA UDI dac2ea18-c5b8-4921-ace4-d1b3c6c546dd 35 fields · synced May 31, 2026