← Back to catalogue

Diamedix

FDA UDI

Class II (US FDA UDI)

by Diamedix Corp.

Identity

Trade Name
Diamedix FDA UDI
Generic Name
Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
Device Name
"720-310 Toxoplasma IgM Test Kit" FDA UDI
Model / Reference
720-310 FDA UDI
Description
"720-310 Toxoplasma IgM Test Kit" FDA UDI

Identifiers

Primary DI / UDI-DI
00817273020143 FDA UDI
510(k) Number
K001707 FDA UDI
FDA Product Code
LGD FDA UDI
GMDN Term
Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3780 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Diamedix by Diamedix Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay.

Cleared under the same submission

K001707 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Diamedix Corp.

Sources (1)

  • FDA UDI 208d761a-a38d-4598-b0a8-b803d3e41705 36 fields · synced May 30, 2026