Collagen

FDA UDI

Class II (US FDA UDI)

by Bio/Data Corp.

Identity

Trade Name: Collagen FDA UDI
Generic Name: Platelet aggregation study IVD, reagent FDA UDI
Model / Reference: Calf Skin Type 1 FDA UDI

Identifiers

Catalog Number: 101562 FDA UDI
Primary DI / UDI-DI: G0561015621 FDA UDI
510(k) Number: K790769 FDA UDI
FDA Product Code: JOZ FDA UDI
GMDN Term: Platelet aggregation study IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.5700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Platelet aggregation study IVD, reagent

Collagen by Bio/Data Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Platelet Aggregation Kit — Helena Laboratories, Corp. · Class II
ADP Reagent — Helena Laboratories, Corp. · Class II
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TEG HEMOSTASIS SYSTEM — HAEMONETICS CORPORATION · Class II

Cleared under the same submission

K790769 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Bio/Data Corp.

Sources (1)

FDA UDI 7a1e2ddc-f092-415c-9fb9-5c2acc28c44c 34 fields · synced May 30, 2026