Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Results for “”
Name, manufacturer or identifier
Search
Manufacturer
(optional)
Filters
1 active
Filters
1 active
Registry
EUDAMED
FDA 510(k) incl. De Novo
2
FDA PMA
GUDID
20
Country / market
United States
22
Risk class
Class I
18
Class IIa
Class IIb
Class III
Class II (US)
3
More classes (11)
Class A
Class B
Class C
Class D
IVD General
IVD Annex II List A
IVD Annex II List B
IVD for self-testing
Active implantable (AIMDD)
Unclassified (FDA)
Not classified (FDA)
Verified
Verified only
Category (EMDN)
Browse by category
Apply filters
Reset
22 devices found
·
sorted by relevance
Key
Manufacturer: Neumodx Molecular, Inc.
×
Clear all
Device
Device · Manufacturer · Authorizations
Verified
Verified
Status
Status
Regime
Regime
Registry
Registry
Class
Class
NeuMoDx CT/NG Assay 2.0
Neumodx Molecular, Inc.
·
,
United States
(FDA applicant)
FDA 510(k)
K230267
Active
Cleared 22 Dec 2023
Active
Regimes:
510(k)
Registry:
510(k)
Class
Class:
II
NeuMoDx GBS Assay
Neumodx Molecular, Inc.
·
,
United States
(FDA applicant)
FDA 510(k)
K173725
Active
Cleared 26 Jun 2018
Active
Regimes:
510(k)
Registry:
510(k)
Class
Class:
I
Previous
Next
Showing 21-22 of 22