← Back to catalogue

Immuno-Trol

FDA UDI

by Theradiag Sa

Identity

Trade Name
IMMUNO-TROL FDA UDI
Generic Name
Phospholipid antibody IVD, control FDA UDI
Device Name
Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoantibodies: anti-Cardiolipin IgM isotype aCL IgM , anti-Phospholipides IgM Isotype aPL IgM , anti-Beta 2 - glycoprotein 1 IgM isotype β2GP1 IgM , anti-Prothrombin IgM isotype FII IgM . FDA UDI
Model / Reference
APS IgM FDA UDI
Description
Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoantibodies: anti-Cardiolipin IgM isotype aCL IgM , anti-Phospholipides IgM Isotype aPL IgM , anti-Beta 2 - glycoprotein 1 IgM isotype β2GP1 IgM , anti-Prothrombin IgM isotype FII IgM . FDA UDI

Identifiers

Catalog Number
HM 063US-2X05 FDA UDI
Primary DI / UDI-DI
03760170782058 FDA UDI
GMDN Term
Phospholipid antibody IVD, control FDA UDI

Classification

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

Yes

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

Category: Phospholipid antibody IVD, control

Immuno-Trol by Theradiag Sa — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Phospholipid antibody IVD, control.

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
Theradiag Sa

Sources (1)

  • FDA UDI a4270e1f-a42a-481e-ad7e-4be6589f3e5e 36 fields · synced Jun 6, 2026