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VaccZyme™ Human Anti-Haemophilus Influenzae type b Enzyme Immunoassay Kit

FDA UDI

Class II (US FDA UDI)

by The Binding Site Group

Identity

Trade Name
VaccZyme™ Human Anti-Haemophilus Influenzae type b Enzyme Immunoassay Kit FDA UDI
Generic Name
Haemophilus influenzae culture isolate antigen IVD, antibody FDA UDI
Model / Reference
MK016 FDA UDI

Identifiers

Primary DI / UDI-DI
05051700006767 FDA UDI
FDA Product Code
GRP FDA UDI
GMDN Term
Haemophilus influenzae culture isolate antigen IVD, antibody FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3300 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

Yes

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: Haemophilus influenzae culture isolate antigen IVD, antibody

VaccZyme™ Human Anti-Haemophilus Influenzae type b Enzyme Immunoassay Kit by The Binding Site Group — Class II — FDA UDI — listed in FDA GUDID

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
The Binding Site Group

Sources (1)

  • FDA UDI bd653800-1554-465e-a91e-c02e04ed75c4 34 fields · synced Jun 8, 2026