ROCHE DIAGNOSTICS OPERATIONS INC

Matched from indexed company URL: Roche Diagnostics Operations, Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1823260	1823260	ROCHE DIAGNOSTICS OPERATIONS INC	1	Y	2026-01-01	9115 Hague Rd Indianapolis IN US 46250

PMA#

Elecsys Anti-HCV II
2019-04-24
ROCHE DIAGNOSTICS OPERATIONS INC
Elecsys HBeAg
2018-11-06
ROCHE DIAGNOSTICS OPERATIONS INC
Elecsys ANti-HCV II (100/200 tests)
2018-11-06
ROCHE DIAGNOSTICS OPERATIONS INC
Elecsys HBcAg
2018-06-13
ROCHE DIAGNOSTICS OPERATIONS INC
Elecsys Anti-HCV II
2018-06-13
ROCHE DIAGNOSTICS OPERATIONS INC
Elecsys Anti-HCV II
2018-04-20
ROCHE DIAGNOSTICS OPERATIONS INC
Elecsys HBeAg and PreciControl HBeAg
2018-03-02
ROCHE DIAGNOSTICS OPERATIONS INC
Elecsys HBeAg
2017-12-20
ROCHE DIAGNOSTICS OPERATIONS INC
Elecsys Anti-HCV II
2017-12-20
ROCHE DIAGNOSTICS OPERATIONS INC
Elecsys Anti-HCV II, PreciControl Anti-HCV
2017-11-03
ROCHE DIAGNOSTICS OPERATIONS INC
Elecsys Anit-HCV II
2017-08-31
ROCHE DIAGNOSTICS OPERATIONS INC
Elecsys HBeAg
2017-08-31
ROCHE DIAGNOSTICS OPERATIONS INC
Elecsys HBeAg and PreciControl HBeAg
2017-08-16
ROCHE DIAGNOSTICS OPERATIONS INC
Elecsys Anti-HCV II Test System
2017-08-10
ROCHE DIAGNOSTICS OPERATIONS INC
Elecsys Anti-HCV II (100/200 tests) Immunoassay
2017-06-23
ROCHE DIAGNOSTICS OPERATIONS INC
Elecsys HBeAg Immunoassay
2017-06-23
ROCHE DIAGNOSTICS OPERATIONS INC
ELECSYS HBEAG AND PRECICONTROL HBEAG
2017-01-13
ROCHE DIAGNOSTICS OPERATIONS INC
ELECSYS HBEAG
2016-11-22
ROCHE DIAGNOSTICS OPERATIONS INC
ELECSYS ANTI-HCV II IMMUNOASSAY.
2016-11-10
ROCHE DIAGNOSTICS OPERATIONS INC
ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG
2016-10-24
ROCHE DIAGNOSTICS OPERATIONS INC
ELECSYS ANTI-HCV II IMMUNOASSAY
2016-08-08
ROCHE DIAGNOSTICS OPERATIONS INC
ELECSYS HBEAG IMMUNOASSAY
2016-08-08
ROCHE DIAGNOSTICS OPERATIONS INC
ELECSYS ANTI-HCV II TEST SYSTEM
2016-07-25
ROCHE DIAGNOSTICS OPERATIONS INC
ELECSYS ANTI-HCV II IMMUNOASSAY
2016-04-12
ROCHE DIAGNOSTICS OPERATIONS INC
ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG
2016-03-16
ROCHE DIAGNOSTICS OPERATIONS INC
ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV
2016-03-16
ROCHE DIAGNOSTICS OPERATIONS INC
ELECSYS ANTI-HCV II TEST SYSTEM
2016-02-24
ROCHE DIAGNOSTICS OPERATIONS INC
ELECSYS ANTI-HCV II
2015-11-24
ROCHE DIAGNOSTICS OPERATIONS INC
ELECSYS HBEAG
2015-11-24
ROCHE DIAGNOSTICS OPERATIONS INC
ELECSYS HBEAG IMMUNOASSAY/ELECSYS PRECICONTROL HBEAG
2015-07-28
ROCHE DIAGNOSTICS OPERATIONS INC
ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV
2015-06-11
ROCHE DIAGNOSTICS OPERATIONS INC
ELECSYS HBEAG ON MODULAR ANALYTICS E170
2014-11-26
ROCHE DIAGNOSTICS OPERATIONS INC
ELECSYS HBEAG IMMUNOASSAY AND ELECSYS PRECICONTROL HBEAG
2014-06-06
ROCHE DIAGNOSTICS OPERATIONS INC
ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG
2014-03-14
ROCHE DIAGNOSTICS OPERATIONS INC

PMN#

Tina-quant Lipoprotein(a) Gen.2 Molarity
2025-01-24
Roche Diagnostics Operations
ONLINE TDM Methotrexate
2024-02-20
Roche Diagnostics Operations
Tina-quant Hemoglobin A1cDx Gen.3
2020-03-26
Roche Diagnostics Operations (RDO)
Tina-quant C-Reactive Protein IV
2020-02-21
Roche Diagnostics Operations (RDO)
Ammonia II
2019-02-08
Roche Diagnostics Operations (RDO)
Tina-quant Transferrin Ver.2 (urine Application)
2018-11-05
Roche Diagnostics Operations (RDO)
Cobas HbA1c Test, Cobas B 101 System
2017-07-28
Roche Diagnostics Operations
ALP IFCC Gen.2
2017-05-10
Roche Diagnostics Operations (RDO)
Cobas C513 Analyzer, Cobas C13 Tina-quant HbA1cDx Gen.3 Assay
2016-12-19
Roche Diagnostics Operations (RDO)
HDL-Cholesterol Gen.4
2016-10-19
Roche Diagnostics Operations (RDO)
Tina-quant Cystatin C Gen.2
2016-07-27
Roche Diagnostics Operations (RDO)
Creatine Kinase
2016-05-25
Roche Diagnostics Operations (RDO)
ONLINE TDM Vancomycin Gen.3
2016-01-08
ROCHE DIAGNOSTICS OPERATIONS (RDO)
Carbamazepine Gen 4
2015-10-22
Roche Diagnostics Operations (RDO)
LDLC3 LDL-Cholesterol Gen.3
2015-01-28
Roche Diagnostics Operations (RDO)
TOTAL PROTEIN URINE/CSF GEN.3
2014-12-09
Roche Diagnostics Operations (RDO)
COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR
2014-11-25
Roche Diagnostics Operations (RDO)
ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM
2013-10-11
ROCHE DIAGNOSTICS OPERATIONS INC
ACCU-CHEK AVIVA PLUS TEST STRIP
2013-08-09
ROCHE DIAGNOSTICS OPERATIONS INC
COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY
2013-08-08
ROCHE DIAGNOSTICS OPERATIONS
TINA-QUANT ALBUMIN GEN.2
2012-05-14
ROCHE DIAGNOSTICS OPERATIONS

GUDID#

ACCU-CHEK GUIDE - ACCU-CHEK GUIDE CASH VALUE KIT
Roche Diagnostics Operations, Inc.
2025-03-20
ACCU-CHEK GUIDE - ACCU-CHEK GUIDE CASH US 30CT STRIP
Roche Diagnostics Operations, Inc.
2025-03-20
ACCU-CHECK GUIDE - ACCU-CHEK GUIDE CASH US 60CT STRIP
Roche Diagnostics Operations, Inc.
2025-03-20
ACCU-CHEK GUIDE - VIAL LBLD 30CT STRIP ACCU-CHEK GUIDE
Roche Diagnostics Operations, Inc.
2025-03-20
ACCU-CHEK GUIDE - ACCU-CHEK GUIDE CASH VALUE KIT
Roche Diagnostics Operations, Inc.
2025-03-20
ACCU-CHEK GUIDE - ACCU-CHEK GUIDE CASH US 30CT STRIP
Roche Diagnostics Operations, Inc.
2025-03-20
ACCU-CHECK GUIDE - ACCU-CHEK GUIDE CASH US 60CT STRIP
Roche Diagnostics Operations, Inc.
2025-03-20
Accu-Chek Guide Me - Accu-Chek Guide Me Retail Kit mg/dl US
Roche Diagnostics Operations, Inc.
2019-04-08
Accu-Chek Guide - Accu-Chek Guide Retail Kit FCN mg/dl US
Roche Diagnostics Operations, Inc.
2018-03-02
ACCU-CHEK GUIDE LINK - ACCU-CHEK GUIDE LINK SAMPLE mg/dl MO US
Roche Diagnostics Operations, Inc.
2023-09-21
ACCU-CHEK GUIDE LINK - ACCU-CHEK GUIDE LINK MG/DL 118
Roche Diagnostics Operations, Inc.
2023-09-21
ACCU-CHEK GUIDE LINK - ACCU-CHEK GUIDE LINK SAMPLE mg/dl MO US
Roche Diagnostics Operations, Inc.
2023-09-21
ACCU-CHEK GUIDE LINK - Accu-Chek Guide Link SC mg/dL
Roche Diagnostics Operations, Inc.
2023-09-06
ACCU-CHEK GUIDE LINK - Accu-Chek Guide Link MO Replacement US
Roche Diagnostics Operations, Inc.
2023-09-06
ACCU-CHEK GUIDE LINK - Accu-Chek Guide Link SC mg/dL
Roche Diagnostics Operations, Inc.
2023-09-06
ACCU-CHEK GUIDE LINK - Accu-Chek Guide Link MO Replacement US
Roche Diagnostics Operations, Inc.
2023-09-06
Accu-Chek Aviva - ACCU-CHEK AVIVA PLUS SAMPLE KIT 20/CASE
Roche Diagnostics Operations, Inc.
2018-03-01
Accu-Chek Aviva - ACCU-CHEK AVIVA MG/DL 455 US NON-VA
Roche Diagnostics Operations, Inc.
2019-02-28
ACCU-CHEK AVIVA PLUS - ACCU-CHEK AVIVA PLUS HNP KIT 8/CASE
Roche Diagnostics Operations, Inc.
2016-08-26
ACCU-CHEK AVIVA PLUS - ACCU-CHEK AVIVA PLUS 10CT STRIP BRK
Roche Diagnostics Operations, Inc.
2016-08-26
ACCU-CHEK AVIVA - ACCU-CHEK AVIVA MG/DL 455 US
Roche Diagnostics Operations, Inc.
2016-08-26
ACCU-CHEK AVIVA CONNECT - ACCU-CHEK AVIVA CONNECT MG/DL (502)
Roche Diagnostics Operations, Inc.
2016-08-26
ACCU-CHEK NANO - ACCU-CHEK NANO MTR MG/DL (596)
Roche Diagnostics Operations, Inc.
2016-08-26
ACCU-CHEK AVIVA EXPERT - ACCU-CHEK AVIVA EXPERT MG/DL (650)
Roche Diagnostics Operations, Inc.
2016-08-26
ACCU-CHEK AVIVA COMBO - ACCU-CHEK AVIVA COMBO MG/DL (670)
Roche Diagnostics Operations, Inc.
2016-08-08
ACCU-CHEK PERFORMA - ACCU-CHEK PERFORMA METER MG/DL (550)
Roche Diagnostics Operations, Inc.
2016-08-26
Accu-Chek Aviva - Accu-Chek Aviva Plus Retail Kit 10/case
Roche Diagnostics Operations, Inc.
2018-03-01
Accu-Chek Aviva - ACCU-CHEK AVIVA PLUS METER ONLY US
Roche Diagnostics Operations, Inc.
2018-03-01
ACCU-CHEK GUIDE - ACCU-CHEK GUIDE METER ONLY MG/DL US
Roche Diagnostics Operations, Inc.
2017-02-02
ACCU-CHEK COMPACT PLUS - ACCU-CHEK COMPACT PLUS CARE KIT 8/CASE
Roche Diagnostics Operations, Inc.
2016-08-26
ACCU-CHEK COMPACT PLUS - ACCU-CHEK COMPACT PLUS SAMPLE KIT 16/CS
Roche Diagnostics Operations, Inc.
2016-08-26
ACCU-CHEK COMPACT PLUS - ACCU-CHEK COMPACT PLUS DME KIT
Roche Diagnostics Operations, Inc.
2016-08-26
ACCU-CHEK NANO - ACCU-CHEK NANO SAMPLE KIT 16/CASE
Roche Diagnostics Operations, Inc.
2016-08-26
ACCU-CHEK NANO - ACCU-CHEK NANO RETAIL KIT 8/CASE
Roche Diagnostics Operations, Inc.
2016-08-26
ACCU-CHEK AVIVA CONNECT - ACCU-CHEK AVIVA CONNECT SAMPLE KIT 16/CASE
Roche Diagnostics Operations, Inc.
2016-08-26
ACCU-CHEK AVIVA CONNECT - ACCU-CHEK AVIVA CONNECT RETAIL KIT 8/CASE
Roche Diagnostics Operations, Inc.
2016-08-26
ACCU-CHEK AVIVA CONNECT - ACCU-CHEK AVIVA CONNECT MG/DL M-O
Roche Diagnostics Operations, Inc.
2016-08-26
ACCU-CHEK GUIDE - ACCU-CHEK GUIDE SAMPLE KIT MG/DL
Roche Diagnostics Operations, Inc.
2017-02-02
Accu-Chek Guide Link - ACCU-CHEK GUIDE LINK FC US MG/DL
Roche Diagnostics Operations, Inc.
2020-10-30
Accu-Chek Guide - Accu-Chek Guide Sample Kit FCN mg/dl US
Roche Diagnostics Operations, Inc.
2018-06-01

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