Aptiva Celiac Disease IgG Calibrators

EUDAMEDFDA UDI

Class B (EU MDR)

Ref 724101

by Inova Diagnostics. Inc.

Identity

Trade Name: Aptiva Celiac Disease IgG Calibrators EUDAMED
Aptiva EUDAMED
Aptiva® Celiac Disease IgG Calibrators FDA UDI
Generic Name: Multiple Coeliac disease-associated antibody IVD, calibrator FDA UDI
Device Name: Aptiva Celiac Disease IgG Calibrators EUDAMED
Aptiva® Celiac Disease IgG Calibrators EUDAMED
The Celiac Disease IgG Calibrators include antibodies to tTG and DGP. 1. Aptiva Celiac IgG Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives. 2. Aptiva Celiac IgG Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives. 3. Aptiva Celiac IgG Calibrator 3: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives. FDA UDI
Model / Reference: 724101 EUDAMEDFDA UDI
Description: The Celiac Disease IgG Calibrators include antibodies to tTG and DGP. 1. Aptiva Celiac IgG Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives. 2. Aptiva Celiac IgG Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives. 3. Aptiva Celiac IgG Calibrator 3: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives. FDA UDI

Identifiers

Primary DI / UDI-DI: 08430793040518 EUDAMEDFDA UDI
Basic UDI-DI: 84307930405183L EUDAMED
B-08430793040518 EUDAMED
FDA Product Code: JIX FDA UDI
EMDN Code: W0102152211 STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY EUDAMED
GMDN Term: Multiple Coeliac disease-associated antibody IVD, calibrator FDA UDI

Classification

Device Class: Class B EUDAMED
Class IVD General EUDAMED
Class II FDA UDI
Regulation Number: 862.1150 FDA UDI
Market of Registration: Italy EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Aptiva Celiac Disease IgG Calibrators by Inova Diagnostics, Inc. — Class B — IVDD, IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

European Union Active

CE/IVDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	84307930405183L	Class B	Active
EUDAMED	European Union	CE/IVDR	84307930405183L	Class B	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class B	Pending data

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Manufacturer

Manufacturer: Inova Diagnostics. Inc.
EUDAMED SRN: US-MF-000017851
Authorised Representative: Medical Technology Promedt Consulting GmbH DE-AR-000000085

Sources (3)

EUDAMED 238e4e6b-0c4a-4770-8edf-0c665b2b94e5 61 fields · synced Jul 12, 2026
EUDAMED 4f769357-46b9-4d40-89a4-cb70cf156a5c 61 fields · synced May 18, 2026
FDA UDI 1e92ac96-224d-4b81-9220-e7c97205df03 35 fields · synced May 30, 2026