Identity
- Trade Name
- Negative Control Mo IgM FDA UDI
- Generic Name
- Immunoglobulin M subclass (IgM subclass) IVD, control FDA UDI
- Device Name
- Negative Control Mouse IgM FDA UDI
- Model / Reference
- X0942 FDA UDI
- Description
- Negative Control Mouse IgM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700572009627 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Immunoglobulin M subclass (IgM subclass) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Dimensions & Sizes
- Size
- Total Volume — 1 Milliliter FDA UDI
Category: Immunoglobulin M subclass (IgM subclass) IVD, control
Negative Control Mo IgM by Agilent Technologies Singapore Pte Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Immunoglobulin M subclass (IgM subclass) IVD, control.
- IgM Control Slides — BIO SB, INC. · 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
- Agilent Technologies Singapore Pte Ltd
Sources (1)
- FDA UDI 08cd12cc-7fb9-40a4-b61b-ac13d1bd17fa 36 fields · synced Jun 6, 2026