lgcgroup.comAccuPlex™ Febrile Illness Control Pack - 2800-0144
2026-09-18
LGC Clinical Diagnostics, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1226774 | 3003407015 | LGC Clinical Diagnostics, Inc. | 1 | N | 2026-01-01 | 221 US Route 1 Cumberland Foreside ME US 04110 |
| 3003610890 | 3003610890 | LGC Clinical Diagnostics, Inc. | 1 | N | 2026-01-01 | 910 Clopper road Gaithersburg MD US 20878 |
| 3007088335 | 1220394 | LGC Clinical Diagnostics, Inc. | 1 | N | 2026-01-01 | 37 Birch St Milford MA US 01757 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850011135853 | Validate - Validate SP1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | 1-800-377-9684 | MSC.info@LGCGroup.com |
| 00850011135884 | VALIDATE - VALIDATE HBsAg Calibration Verification / Linearity Test Kit | 1-207-892-1300 | CDx-Info@lgcgroup.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 83148 | 1288535508 | K974261 | ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL | LJK | 1997-12-11 |
| 83148 | 1685935231 | K972986 | ACCURUN 140 RUBELLA IGG POSITIVE CONTROL | MJX | 1997-10-08 |
| 83148 | 1471349649 | K972884 | ACCURUN 146 CMV IGM POSITIVE CONTROL | LKQ | 1997-08-22 |
| 83148 | 1686505926 | K972307 | ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL | JJY | 1997-08-07 |
| 83148 | 1026228620 | K972048 | ACCURUN 117 HBEAG POSITIVE CONTROL | JJY | 1997-08-12 |
| 299097 | 1042582927 | K170864 | VALIDATE D-Dimer Calibration Verification / Linearity Test Kit | GGN | 2017-06-21 |
| 299097 | 2035617197 | K163498 | VALIDATE Heparin Calibration Verification/Linearity Test Kit | GGN | 2017-03-16 |
| 299097 | 1362396410 | K162705 | VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit | GGN | 2017-01-05 |
| 299097 | 2040286002 | K152961 | VALIDATE D-Dimer Calibration Verification/Linearity Test Kit | GGN | 2016-06-03 |
| 299097 | 1243526304 | K123127 | VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 | JJX | 2013-06-14 |
| 299097 | 1380055628 | K113524 | VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT | JJX | 2012-01-27 |
| 299097 | 1202889270 | K091225 | VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET | JJY | 2009-06-25 |
| 299097 | 1145619848 | K090475 | VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402 | JJY | 2009-04-16 |
| 299097 | 1671798573 | K083891 | VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 | JJY | 2009-03-23 |
| 299097 | 1077274438 | K072246 | VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601 | JJY | 2007-09-14 |
| 299097 | 1136923116 | K053247 | VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET | JJY | 2006-01-13 |
| 299097 | 1348943992 | K050504 | VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS | JJY | 2005-03-25 |
| 299097 | 1739964655 | K041975 | VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501 | JJY | 2004-10-15 |
| 299097 | 1635134306 | K033879 | VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 | DKB | 2004-02-27 |
| 299097 | 1217361396 | K012120 | VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004 | JJY | 2001-08-20 |
| 299097 | 1503576888 | K012117 | VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001 | JJY | 2001-08-20 |
| 83148 | 1972991851 | BK990032 | |||
| 83148 | 1725791759 | BK970004 | |||
| 83148 | 1266691538 | BK930027 | |||
| 83148 | 1971502910 | BK060022 | |||
| 83148 | 1547109327 | BK040067 | |||
| 83148 | 1170268785 | BK040064 | |||
| 83148 | 1606213675 | BK040016 | |||
| 83148 | 1548118743 | BK040006 | |||
| 83148 | 1937552633 | BK010038 | |||
| 83148 | 1429070760 | ||||
| 83148 | 1049847026 | ||||
| 272867 | 1049847026 | ||||
| 299097 | 1049847026 | ||||
| 299097 | 1184940082 | ||||
| 299097 | 1294546098 | ||||
| 83148 | 1294546098 | ||||
| 272867 | 1317526505 | ||||
| 83148 | 1317526505 | ||||
| 299097 | 1317526505 | ||||
| 83148 | 1319510354 | ||||
| 299097 | 1319510354 | ||||
| 299097 | 1429070760 | ||||
| 272867 | 1429070760 | ||||
| 83148 | 1812841083 | ||||
| 272867 | 1812841083 | ||||
| 299097 | 1851267734 |
Product Codes Associated With Registrations#
GUDID#
VALIDATE - VALIDATE HBsAg Calibration Verification / Linearity Test Kit
2026-08-25
Validate - Validate SP1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
2026-07-07
Refractrol SP Normal - Refractrol™ SP is a reference control consisting of bovine serum albumin in a synthetic matrix. It is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures for total serum protein values, as measured by digital and analog refractometer procedures. Refractrol SP controls are provided with quantitative concentration values obtained by testing on multiple refractometry systems. For professional laboratory use only.
2026-07-30
Refractrol SP 9.0 High - Refractrol™ 6.0 Low and Refractrol 9.0 High are reference controls consisting of bovine serum albumin in a synthetic matrix. They are intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures for total serum protein values, as measured by digital and analog refractometer procedures. Refractrol 6.0 Low and Refractrol 9.0 High controls are provided with quantitative concentration values obtained by testing on multiple refractometry systems. For professional laboratory use only.
2026-07-30
Refractrol SP High - Refractrol™ SP is a reference control consisting of bovine serum albumin in a synthetic matrix. It is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures for total serum protein values, as measured by digital and analog refractometer procedures. Refractrol SP controls are provided with quantitative concentration values obtained by testing on multiple refractometry systems. For professional laboratory use only.
2026-07-30
Refractrol SP Low - Refractrol™ SP is a reference control consisting of bovine serum albumin in a synthetic matrix. It is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures for total serum protein values, as measured by digital and analog refractometer procedures. Refractrol SP controls are provided with quantitative concentration values obtained by testing on multiple refractometry systems. For professional laboratory use only.
2026-07-30
Refractrol SP 6.0 Low - Refractrol™ 6.0 Low and Refractrol 9.0 High are reference controls consisting of bovine serum albumin in a synthetic matrix. They are intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures for total serum protein values, as measured by digital and analog refractometer procedures. Refractrol 6.0 Low and Refractrol 9.0 High controls are provided with quantitative concentration values obtained by testing on multiple refractometry systems. For professional laboratory use only.
2026-07-28
VALIDATE - VALIDATE® LCMS TDM Test Set
2026-07-07
VALIDATE - VALIDATE Anti-HEV Plasma Calibration Verification / Linearity Test Kit
2026-06-05
VALIDATE - VALIDATE PRO-C3 Calibration Verification / Linearity Test Kit
2026-06-02
VALIDATE - VALIDATE High Sensitive Troponin is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
2026-04-29
VALIDATE - Validate LCMS ISx Test Kit
2026-04-24
KOVA-Trol II Low Abnormal - KOVA-Trol is a freeze-dried preparation of human urine. It is intended for use in the clinical laboratory as a urine control forqualitative and semi-quantitative procedures used in physiochemical and chemical determinations and for microscopicsediment analyses.For professional laboratory use only.
2026-04-17
KOVA-Trol III Normal with hCG - KOVA-Trol is a freeze-dried preparation of human urine. It is intended for use in the clinical laboratory as a urine control forqualitative and semi-quantitative procedures used in physiochemical and chemical determinations and for microscopicsediment analyses.For professional laboratory use only.
2026-04-17
KOVA-Trol III Normal with hCG - KOVA-Trol is a freeze-dried preparation of human urine. It is intended for use in the clinical laboratory as a urine control forqualitative and semi-quantitative procedures used in physiochemical and chemical determinations and for microscopicsediment analyses.For professional laboratory use only.
2026-04-17
KOVA-Trol I High Abnormal With Urobilinogen - KOVA-Trol is a freeze-dried preparation of human urine. It is intended for use in the clinical laboratory as a urine control forqualitative and semi-quantitative procedures used in physiochemical and chemical determinations and for microscopicsediment analyses.For professional laboratory use only.
2026-04-17
KOVA-Trol I High Abnormal With Urobilinogen - KOVA-Trol is a freeze-dried preparation of human urine. It is intended for use in the clinical laboratory as a urine control forqualitative and semi-quantitative procedures used in physiochemical and chemical determinations and for microscopicsediment analyses.For professional laboratory use only.
2026-04-17
KOVA-Trol III Normal with hCG - KOVA-Trol is a freeze-dried preparation of human urine. It is intended for use in the clinical laboratory as a urine control forqualitative and semi-quantitative procedures used in physiochemical and chemical determinations and for microscopicsediment analyses.For professional laboratory use only.
2026-04-17
KOVA-Trol I High Abnormal with Urobilinogen Value Assignment - KOVA-Trol is a freeze-dried preparation of human urine. It is intended for use in the clinical laboratory as a urine control forqualitative and semi-quantitative procedures used in physiochemical and chemical determinations and for microscopicsediment analyses.For professional laboratory use only.
2026-04-17
Optitrol NAT Triplex - NT01042
2026-01-30
Optitrol NAT Triplex - NT01041
2026-01-30
Optitrol HEPR-2 - SR12055
2026-01-30
Optitrol HEPR-2 - SR12057
2026-01-30
Optitrol Mumps M - SR15065
2026-01-30
Optitrol Mumps M - SR15067
2026-01-30
Optitrol Mumps M - SR15068
2026-01-30
VALIDATE - VALIDATE pTau217 Plasma Calibration Verification / Linearity Test Kit
2026-01-06
ACCURUN EBV DNA Positive Control - 2020-0210
2025-11-21
ACCURUN BKV DNA Positive Control - 2020-0209
2025-11-21
Optitrol Blue - SR11011
2025-10-30
Optitrol Blue - SR11013
2025-10-30
Optitrol Blue - SR11019
2025-10-30
VALIDATE - VALIDATE SP2 Calibration Verification / Linearity Test Kit
2025-10-08
VALIDATE - VALIDATE SP3 Calibration Verification / Linearity Test Kit
2025-10-08
Validate - Validate CM2 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
2020-03-02
AccuTrak - AccuTrak Abeta42 Calibration Verification Panel
2025-07-21
Validate - VALIDATE Growth Hormone IVD Control
2022-02-09
VALIDATE - VALIDATE pTau181 CSF Calibration Verification / Linearity Test Kit
2025-07-08
VALIDATE - VALIDATE tTau CSF Calibration Verification / Linearity Test Kit
2025-07-08