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Human IgM kit for use on SPAPLUS- Bulk Kit

FDA UDI

Class II (US FDA UDI)

by The Binding Site Group

Identity

Trade Name
Human IgM kit for use on SPAPLUS- Bulk Kit FDA UDI
Generic Name
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry FDA UDI
Model / Reference
NK012.10S FDA UDI

Identifiers

Primary DI / UDI-DI
05051700016698 FDA UDI
510(k) Number
K082129 FDA UDI
FDA Product Code
CFN FDA UDI
JJX FDA UDI
JIT FDA UDI
GMDN Term
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5510 FDA UDI
862.1660 FDA UDI
862.1150 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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 M (IgM total) IVD, kit, nephelometry/turbidimetry

Human IgM kit for use on SPAPLUS- Bulk Kit by The Binding Site Group — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry.

Cleared under the same submission

K082129 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
The Binding Site Group

Sources (1)

  • FDA UDI 1cdc3de0-b5d6-4491-8816-f841807a46fb 35 fields · synced Jun 8, 2026