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Ihc

FDA UDI

Class I (US FDA UDI)

by Slmp, LLC

Identity

Trade Name
IHC FDA UDI
Generic Name
Total immunoglobulin G (IgG total) IVD, antibody FDA UDI
Device Name
IgG Antibody, 10ml FDA UDI
Model / Reference
(BTO) RTU IgG Antibody (10ml) FDA UDI
Description
IgG Antibody, 10ml FDA UDI

Identifiers

Catalog Number
RP08-10 FDA UDI
Primary DI / UDI-DI
00810170552090 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Total immunoglobulin G (IgG total) IVD, antibody 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

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Total immunoglobulin G (IgG total) IVD, antibody

Ihc by Slmp, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total immunoglobulin G (IgG total) IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Slmp, LLC

Sources (1)

  • FDA UDI c4e2e343-6606-4535-83c3-72e0b0d7139b 34 fields · synced May 31, 2026