← Back to catalogue

ZYMUTEST HIA IgGAM

FDA UDI

Class II (US FDA UDI)

by Hyphen Biomed

Identity

Trade Name
ZYMUTEST HIA IgGAM FDA UDI
Generic Name
Polyvalent human immunoglobulin antibody IVD, antibody FDA UDI
Model / Reference
RK040D FDA UDI

Identifiers

Catalog Number
RK040D FDA UDI
Primary DI / UDI-DI
03663537018770 FDA UDI
510(k) Number
K071255 FDA UDI
FDA Product Code
LCO FDA UDI
GMDN Term
Polyvalent human immunoglobulin antibody IVD, antibody FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7695 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

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: Polyvalent human immunoglobulin antibody IVD, antibody

ZYMUTEST HIA IgGAM by Hyphen Biomed — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyvalent human immunoglobulin antibody IVD, antibody.

Cleared under the same submission

K071255 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
Hyphen Biomed

Sources (1)

  • FDA UDI daf827c0-32ce-4adc-921c-ab2f8d1decb2 35 fields · synced May 30, 2026