# First Sign FSCCUP-34124

> Listed: FDA GUDID listing, no authorization on record. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/first-sign-fsccup-34124>
- Manufacturer: [Hemosure Inc.](https://devicerts.com/manufacturers/hemosure-inc) (FDA registration: United States)
- Device class: Class II (US FDA)
- FDA product code: DKZ, JXM, DJG, DIS, LAF, DIO, DJR, LDJ
- GMDN: Multiple drugs of abuse IVD, kit, rapid ICT, clinical (46994)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 00817763022954 · listed 2026-09-03 · status: Listed (GUDID: in commercial distribution)

## Recalls

No recall on record.

## Identity

- Trade name: First Sign [FDA GUDID (AccessGUDID)]
- Generic name: Multiple drugs of abuse IVD, kit, rapid ICT, clinical [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: FSCCUP-34124 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00817763022954 [FDA GUDID (AccessGUDID)]
- FDA product code: DKZ [FDA GUDID (AccessGUDID)]; JXM [FDA GUDID (AccessGUDID)]; DJG [FDA GUDID (AccessGUDID)]; DIS [FDA GUDID (AccessGUDID)]; LAF [FDA GUDID (AccessGUDID)]; DIO [FDA GUDID (AccessGUDID)]; DJR [FDA GUDID (AccessGUDID)]; LDJ [FDA GUDID (AccessGUDID)]
- GMDN term: Multiple drugs of abuse IVD, kit, rapid ICT, clinical (46994) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 862.3100 [FDA GUDID (AccessGUDID)]; 862.3170 [FDA GUDID (AccessGUDID)]; 862.3650 [FDA GUDID (AccessGUDID)]; 862.3150 [FDA GUDID (AccessGUDID)]; 862.3610 [FDA GUDID (AccessGUDID)]; 862.3250 [FDA GUDID (AccessGUDID)]; 862.3620 [FDA GUDID (AccessGUDID)]; 862.3870 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Single use: Yes [FDA GUDID (AccessGUDID)]
- Over-the-counter: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: First Sign FSCCUP-34124, Hemosure Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/first-sign-fsccup-34124 (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/first-sign-fsccup-34124.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/first-sign-fsccup-34124
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.