Identity
- Trade Name
- IH-Card Control FDA UDI
- Generic Name
- Antisera matrix (non-reactive) IVD, control FDA UDI
- Device Name
- Optional card for the negative control in ABO and Rh typing; 12 cards of 6 microtubes FDA UDI
- Model / Reference
- 813600100 FDA UDI
- Description
- Optional card for the negative control in ABO and Rh typing; 12 cards of 6 microtubes FDA UDI
Identifiers
- Catalog Number
- 813600100 FDA UDI
- Primary DI / UDI-DI
- 07611969952212 FDA UDI
- FDA Product Code
- KSF FDA UDI
- GMDN Term
- Antisera matrix (non-reactive) IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9650 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: Antisera matrix (non-reactive) IVD, control
IH-Card Control by Bio-Rad Medical Diagnostics GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Antisera matrix (non-reactive) IVD, control.
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- ORTHO — Ortho-Clinical Diagnostics · Class I
- Seraclone Control AB0+Rh — Bio-Rad Medical Diagnostics GmbH · 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
- Bio-Rad Medical Diagnostics GmbH
Sources (1)
- FDA UDI e481c569-ff3b-4d7f-bc47-b119c692542f 37 fields · synced May 30, 2026