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Rabbit Coagulase Plasma (10x3ml)

FDA UDI

Class I (US FDA UDI)

by Pro-Lab, Incorporated

Identity

Trade Name
Rabbit Coagulase Plasma (10x3ml) FDA UDI
Generic Name
Coagulase production microbial reagent IVD FDA UDI
Device Name
Rabbit Coagulase Plasma is a standardized, lyophilised rabbit plasma used for the qualitative detection of the coagulase enzyme produced by Staphylococcus aureus. FDA UDI
Model / Reference
PL.850-3 FDA UDI
Description
Rabbit Coagulase Plasma is a standardized, lyophilised rabbit plasma used for the qualitative detection of the coagulase enzyme produced by Staphylococcus aureus. FDA UDI

Identifiers

Catalog Number
PL.850-3 FDA UDI
Primary DI / UDI-DI
05060472467515 FDA UDI
FDA Product Code
JTL FDA UDI
GMDN Term
Coagulase production microbial reagent IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2160 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

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: Coagulase production microbial reagent IVD

Rabbit Coagulase Plasma (10x3ml) by Pro-Lab, Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coagulase production microbial reagent IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pro-Lab, Incorporated

Sources (1)

  • FDA UDI d695b3e3-8660-4393-970a-52f77a9051e8 34 fields · synced May 30, 2026