510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Gentian AS

Moss Ostfold, NO

Gentian AS appears in FDA device records in Moss Ostfold, NO. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Gentian AS between 2007 and 2008. The busiest year on record is 2007, with 1. The most recent is 2008, with 1.

Clearances by year, as a table
510(k) clearance decisions for Gentian AS, by decision year
YearClearances
20071
20081
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K081875GENTIAN CYSTATIN C IMMUNOASSAYNDYSubstantially Equivalent
K071388GENTIAN CYSTATIN C IMMUNOASSAYNDYSubstantially Equivalent

Registered establishments

FDA registered establishments for Gentian AS, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30068012413006801241Gentian ASBjornasveien 5, Moss Ostfold N-1596 NO2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0099-2021GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07090038460092 2. Gentian C E Calibrator Kit, 6 x 1 mL, REF 1051, UDI: (01)07090038460108 3. Gentian C E, BCI Ref: A52763, Cystatin C calibrator Kit, 6 x 1 mL, REF 1051, (01)17090038460037 4. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 8012 (Not distributed in US)The firm has identified lots of calibrators that have shown to measure incorrect high values over time compared to the assigned values when released for distribution. This could result in higher Cystatin C values measured in patients.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain