Bactidrop India Ink

FDA 510(k)EUDAMED

Class I (US FDA 510(k))

510(k) K920976

Identifiers

510(k) Number: K920976 FDA 510(k)
FDA Product Code: JTS FDA 510(k)

Classification

Device Class: Class I FDA 510(k)
Legislation / Framework: 21 CFR Part 864.1850 FDA 510(k)
Regulation Number: 864.1850 FDA 510(k)
Advisory Committee: Hematology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

BACTIDROP INDIA INK is a microbiologic stain used for the microscopic examination of encapsulated microorganisms in clinical samples. It aids in the identification of encapsulated organisms, such as fungi, to support diagnostic workflows and assist clinicians in evaluating potential fungal infections.

The device is supplied in crushable ampules enclosed in a protective plastic sheath with a convenient dropper dispenser tip, available in packages of 50. It is intended for use in laboratory settings as a diagnostic aid and should be handled according to standard laboratory safety practices. Storage conditions and specific usage instructions should follow the manufacturer's guidelines.

Frequently asked questions

What is BACTIDROP INDIA INK used for?

How is BACTIDROP INDIA INK supplied?

The device is supplied in crushable ampules enclosed in a protective plastic sheath with a convenient dropper dispenser tip. It is available in packages of 50 units.

Where should BACTIDROP INDIA INK be used?

It is intended for use in laboratory settings as a diagnostic aid. Users should handle it according to standard laboratory safety practices and follow the manufacturer's guidelines for storage and specific usage instructions.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Remel™ BactiDrop India Ink 50 Pk. - Thermo Scientific™, Thermo Scientific™ Remel™ BactiDrop India Ink - Fisher Sci, PDF BactiDrop™ India Ink - Thermo Fisher Scientific, Thermo Scientific™ Remel™ BactiDrop™ India Ink |

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	IVDR	—	Class I	Active
FDA 510(k)	United States	FDA_510K	K920976	Class I	Active

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Manufacturer

Manufacturer: Remel, Inc.
FDA Applicant: Remel Co.

Sources (2)

FDA 510(k) K920976 24 fields · synced Sep 28, 2026
EUDAMED 1 fields · synced Jun 4, 2026