Establishments and listings

ASLO Gen2, 200T, cobas c pack green, ASLO TZ, 150Tests, cobas c +7

ROCHE DIAGNOSTICS GMBH · MANNHEIM Baden-Wurttemberg, DE

Repack or Relabel Medical Device +1Reg. 9610126GTQ
Proprietary name
ASLO Gen2, 200T, cobas c pack green, ASLO TZ, 150Tests, cobas c, Tina-quant Apolipoprotein A-1 ver.2, cobas C ASLO TQ, cobas c 70X Antisteptolysin O/400, ASLO TQ, 400Tests, cobas c701, APOAT, 250T, cobas c 503, ASLO Gen2, 400Tests, cobas c701/702, Tina-quant Antistreptolysin-O II
Establishment type
Repack or Relabel Medical Device, Manufacture Medical Device
Registration
Registration number
9610126
FEI number
3002806559
Status code
1
Initial importer flag
N
Reg expiry date year
2027
Name
ROCHE DIAGNOSTICS GMBH
Address line 1
SANDHOFER STRASSE 116
City
MANNHEIM Baden-Wurttemberg
Iso country code
DE
Postal code
D-68305
US agent
Name
Brian Frazier
Business name
Roche Diagnostics Operations Inc
Bus phone area code
317
Bus phone num
5214603
Email address
brian.frazier@roche.com
Address line 1
9115 Hague Rd
City
Indianapolis
State code
IN
Iso country code
US
Zip code
46256
Owner operator
Firm name
Roche Diagnostics Operations Inc.
Owner operator number
9039767
Contact address
Address 1
9115 Hague Road
City
Indianapolis
State code
IN
Iso country code
US
Postal code
46250
Products
  1. Product code
    GTQ
    Created date
    1998-11-25
    Owner operator number
    9039767
    Harmonized identifiers (openFDA)
    Device name
    Antistreptolysin - Titer/Streptolysin O Reagent
    Medical specialty description
    Microbiology
    Regulation number
    866.3720
    Device class
    1
Establishments and listings

Vitamin D total G3 Elecsys cobas e 100, Vitamin D total G3 Elecsys E2G 300 +2

ROCHE DIAGNOSTICS GMBH · MANNHEIM Baden-Wurttemberg, DE

Manufacture Medical DeviceReg. 9610126MRG
K number
K210901
Proprietary name
Vitamin D total G3 Elecsys cobas e 100, Vitamin D total G3 Elecsys E2G 300, Elecsys Vitamin D total III, Vitamin D total G3 Elecsys E2G 100
Establishment type
Manufacture Medical Device
Registration
Registration number
9610126
FEI number
3002806559
Status code
1
Initial importer flag
N
Reg expiry date year
2027
Name
ROCHE DIAGNOSTICS GMBH
Address line 1
SANDHOFER STRASSE 116
City
MANNHEIM Baden-Wurttemberg
Iso country code
DE
Postal code
D-68305
US agent
Name
Brian Frazier
Business name
Roche Diagnostics Operations Inc
Bus phone area code
317
Bus phone num
5214603
Email address
brian.frazier@roche.com
Address line 1
9115 Hague Rd
City
Indianapolis
State code
IN
Iso country code
US
Zip code
46256
Owner operator
Firm name
Roche Diagnostics Operations Inc.
Owner operator number
9039767
Contact address
Address 1
9115 Hague Road
City
Indianapolis
State code
IN
Iso country code
US
Postal code
46250
Products
  1. Product code
    MRG
    Created date
    2021-09-08
    Owner operator number
    9039767
    Harmonized identifiers (openFDA)
    Device name
    System, Test, Vitamin D
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.1825
    Device class
    2
Establishments and listings

Elecsys Syphilis, Syphilis PC Release Elecsys +2

ROCHE DIAGNOSTICS GMBH · MANNHEIM Baden-Wurttemberg, DE

Manufacture Medical DeviceReg. 9610126MYR
K number
BK230839
Proprietary name
Elecsys Syphilis, Syphilis PC Release Elecsys, Syphilis Elecsys E2G 20x300, Syphilis PC Elecsys
Establishment type
Manufacture Medical Device
Registration
Registration number
9610126
FEI number
3002806559
Status code
1
Initial importer flag
N
Reg expiry date year
2027
Name
ROCHE DIAGNOSTICS GMBH
Address line 1
SANDHOFER STRASSE 116
City
MANNHEIM Baden-Wurttemberg
Iso country code
DE
Postal code
D-68305
US agent
Name
Brian Frazier
Business name
Roche Diagnostics Operations Inc
Bus phone area code
317
Bus phone num
5214603
Email address
brian.frazier@roche.com
Address line 1
9115 Hague Rd
City
Indianapolis
State code
IN
Iso country code
US
Zip code
46256
Owner operator
Firm name
Roche Diagnostics Operations Inc.
Owner operator number
9039767
Contact address
Address 1
9115 Hague Road
City
Indianapolis
State code
IN
Iso country code
US
Postal code
46250
Products
  1. Product code
    MYR
    Created date
    2023-08-16
    Owner operator number
    9039767
    Harmonized identifiers (openFDA)
    Device name
    Test, Donor, Syphilis, Antigens, Treponemal
    Medical specialty description
    Microbiology
    Regulation number
    866.3830
    Device class
    2
Establishments and listings

CoaguChek Vantus

ROCHE DIAGNOSTICS GMBH · MANNHEIM Baden-Wurttemberg, DE

Manufacture Medical DeviceReg. 9610126GJS
K number
K170960
Proprietary name
CoaguChek Vantus
Establishment type
Manufacture Medical Device
Registration
Registration number
9610126
FEI number
3002806559
Status code
1
Initial importer flag
N
Reg expiry date year
2027
Name
ROCHE DIAGNOSTICS GMBH
Address line 1
SANDHOFER STRASSE 116
City
MANNHEIM Baden-Wurttemberg
Iso country code
DE
Postal code
D-68305
US agent
Name
Brian Frazier
Business name
Roche Diagnostics Operations Inc
Bus phone area code
317
Bus phone num
5214603
Email address
brian.frazier@roche.com
Address line 1
9115 Hague Rd
City
Indianapolis
State code
IN
Iso country code
US
Zip code
46256
Owner operator
Firm name
Roche Diagnostics Operations Inc.
Owner operator number
9039767
Contact address
Address 1
9115 Hague Road
City
Indianapolis
State code
IN
Iso country code
US
Postal code
46250
Products
  1. Product code
    GJS
    Created date
    2018-01-03
    Owner operator number
    9039767
    Harmonized identifiers (openFDA)
    Device name
    Test, Time, Prothrombin
    Medical specialty description
    Hematology
    Regulation number
    864.7750
    Device class
    2
Establishments and listings

cobas transfer - RRF Heam,Coag 10, cobas bge link +158

ROCHE DIAGNOSTICS GMBH · MANNHEIM Baden-Wurttemberg, DE

Develop Specifications But Do Not Manufacture At This Facility +2Reg. 9610126JQP
Proprietary name
cobas transfer - RRF Heam,Coag 10, cobas bge link, cobas IT 1000, c8100 CRO, cobas Academy, Bulk Loader Module for p512/612, c8100 CLW, c8100 PXT, cobas 8100 RSF, cobas 8100 OBS, Sorting System cobas p312(Kolibri), c8100 BRF, cobas 8100 BCL, c8100 RFX, cobas 8100 AOB, cobas 8100 connection kit, cobas 8100 URF ., cobas 8100 Model Alpha, c8100 SLR, c8100 CRW, c8100 SCM, c8100 Type Alpha, Universal Connection Unit, CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE, conveyor unit, cobas 8100 ACU, c8100 SLL, cobas p701, cobas p501/p701, cobas 8100 BCL - FBT Modification kit, Bulk Loader for cobas p 471, c8100 TLJ, cobas 8100 Signal Tower, output unit, c8100 CLO, c8100 BCL, Liquid Level Detection UPGR Kit, c8100 Beta, Aliquot Tip Loader, cobas connection module +120 more
Establishment type
Develop Specifications But Do Not Manufacture At This Facility, Export Device to the United States But Perform No Other Operation on Device, Manufacture Medical Device
Registration
Registration number
9610126
FEI number
3002806559
Status code
1
Initial importer flag
N
Reg expiry date year
2027
Name
ROCHE DIAGNOSTICS GMBH
Address line 1
SANDHOFER STRASSE 116
City
MANNHEIM Baden-Wurttemberg
Iso country code
DE
Postal code
D-68305
US agent
Name
Brian Frazier
Business name
Roche Diagnostics Operations Inc
Bus phone area code
317
Bus phone num
5214603
Email address
brian.frazier@roche.com
Address line 1
9115 Hague Rd
City
Indianapolis
State code
IN
Iso country code
US
Zip code
46256
Owner operator
Firm name
Roche Diagnostics Operations Inc.
Owner operator number
9039767
Contact address
Address 1
9115 Hague Road
City
Indianapolis
State code
IN
Iso country code
US
Postal code
46250
Products
  1. Product code
    JQP
    Created date
    2008-06-12
    Owner operator number
    9039767
    Harmonized identifiers (openFDA)
    Device name
    Calculator/Data Processing Module, For Clinical Use
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.2100
    Device class
    1
Establishments and listings

SW cobas CT/NG ASAP 11.1, KIT COBAS 6800/8800 CT/NG 480T IVD +12

ROCHE DIAGNOSTICS GMBH · MANNHEIM Baden-Wurttemberg, DE

Export Device to the United States But Perform No Other Operation on DeviceReg. 9610126MKZLSL
K number
K173887
Proprietary name
SW cobas CT/NG ASAP 11.1, KIT COBAS 6800/8800 CT/NG 480T IVD, SW cobas NG ASAP 11.1, SW COBAS 6800/8800 0138.1011, KIT COBAS 6800/8800 CT/NG RMC IVD, SW cobas CT ASAP 11.1, cobas® CT/NG for use on cobas® 6800/8800 systems, KIT COBAS 58/68/8800 CT/NG RMC IVD, cobas® PCR Media Dual Swab Sample Kit, cobas® PCR Urine Sample Kit, cobas® CT/NG Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems, cobas® CT/NG Positive Control Kit, KIT COBAS 58/68/8800 CT/NG 480T IVD, cobas® PCR Media Uni Swab Sample Kit
Establishment type
Export Device to the United States But Perform No Other Operation on Device
Registration
Registration number
9610126
FEI number
3002806559
Status code
1
Initial importer flag
N
Reg expiry date year
2027
Name
ROCHE DIAGNOSTICS GMBH
Address line 1
SANDHOFER STRASSE 116
City
MANNHEIM Baden-Wurttemberg
Iso country code
DE
Postal code
D-68305
US agent
Name
Brian Frazier
Business name
Roche Diagnostics Operations Inc
Bus phone area code
317
Bus phone num
5214603
Email address
brian.frazier@roche.com
Address line 1
9115 Hague Rd
City
Indianapolis
State code
IN
Iso country code
US
Zip code
46256
Owner operator
Firm name
Roche Diagnostics Operations Inc.
Owner operator number
9039767
Contact address
Address 1
9115 Hague Road
City
Indianapolis
State code
IN
Iso country code
US
Postal code
46250
Products
  1. Product code
    MKZ
    Created date
    2018-04-05
    Owner operator number
    9039767
    Harmonized identifiers (openFDA)
    Device name
    Dna Probe, Nucleic Acid Amplification, Chlamydia
    Medical specialty description
    Microbiology
    Regulation number
    866.3120
    Device class
    1
  2. Product code
    LSL
    Created date
    2018-04-05
    Owner operator number
    9039767
    Harmonized identifiers (openFDA)
    Device name
    Dna-Reagents, Neisseria
    Medical specialty description
    Microbiology
    Regulation number
    866.3390
    Device class
    2
  3. Product code
    OOI
    Created date
    2018-04-05
    Owner operator number
    9039767
    Harmonized identifiers (openFDA)
    Device name
    Real Time Nucleic Acid Amplification System
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.2570
    Device class
    2
Establishments and listings

C.F.A.S.PROTEINS IN URINE/CSF, Precinorm PUC +3

ROCHE DIAGNOSTICS GMBH · MANNHEIM Baden-Wurttemberg, DE

Manufacture Medical DeviceReg. 9610126JIXJJY
K number
K050026
Proprietary name
C.F.A.S.PROTEINS IN URINE/CSF, Precinorm PUC, PRECINORM PROTEINS IN URINE/CSF [PUC)], PRECIPATH PROTEINS IN URINE/CSF [PUC], Precipath PUC
Establishment type
Manufacture Medical Device
Registration
Registration number
9610126
FEI number
3002806559
Status code
1
Initial importer flag
N
Reg expiry date year
2027
Name
ROCHE DIAGNOSTICS GMBH
Address line 1
SANDHOFER STRASSE 116
City
MANNHEIM Baden-Wurttemberg
Iso country code
DE
Postal code
D-68305
US agent
Name
Brian Frazier
Business name
Roche Diagnostics Operations Inc
Bus phone area code
317
Bus phone num
5214603
Email address
brian.frazier@roche.com
Address line 1
9115 Hague Rd
City
Indianapolis
State code
IN
Iso country code
US
Zip code
46256
Owner operator
Firm name
Roche Diagnostics Operations Inc.
Owner operator number
9039767
Contact address
Address 1
9115 Hague Road
City
Indianapolis
State code
IN
Iso country code
US
Postal code
46250
Products
  1. Product code
    JIX
    Created date
    2008-05-30
    Owner operator number
    9039767
    Harmonized identifiers (openFDA)
    Device name
    Calibrator, Multi-Analyte Mixture
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.1150
    Device class
    2
  2. Product code
    JJY
    Created date
    2008-05-30
    Owner operator number
    9039767
    Harmonized identifiers (openFDA)
    Device name
    Multi-Analyte Controls, All Kinds (Assayed)
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.1660
    Device class
    1
Establishments and listings

cobas COCAINE, cobas COCAINE/200 +3

ROCHE DIAGNOSTICS GMBH · MANNHEIM Baden-Wurttemberg, DE

Manufacture Medical DeviceReg. 9610126DIO
K number
K023281
Proprietary name
cobas COCAINE, cobas COCAINE/200, COC Gen.2, 850Tests, cobas c503, Cocaine, ONLINE DAT II COCAINE II
Establishment type
Manufacture Medical Device
Registration
Registration number
9610126
FEI number
3002806559
Status code
1
Initial importer flag
N
Reg expiry date year
2027
Name
ROCHE DIAGNOSTICS GMBH
Address line 1
SANDHOFER STRASSE 116
City
MANNHEIM Baden-Wurttemberg
Iso country code
DE
Postal code
D-68305
US agent
Name
Brian Frazier
Business name
Roche Diagnostics Operations Inc
Bus phone area code
317
Bus phone num
5214603
Email address
brian.frazier@roche.com
Address line 1
9115 Hague Rd
City
Indianapolis
State code
IN
Iso country code
US
Zip code
46256
Owner operator
Firm name
Roche Diagnostics Operations Inc.
Owner operator number
9039767
Contact address
Address 1
9115 Hague Road
City
Indianapolis
State code
IN
Iso country code
US
Postal code
46250
Products
  1. Product code
    DIO
    Created date
    2009-02-27
    Owner operator number
    9039767
    Harmonized identifiers (openFDA)
    Device name
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites
    Medical specialty description
    Clinical Toxicology
    Regulation number
    862.3250
    Device class
    2
Establishments and listings

MTX Calibrator

ROCHE DIAGNOSTICS GMBH · MANNHEIM Baden-Wurttemberg, DE

Manufacture Medical DeviceReg. 9610126DLJ
Proprietary name
MTX Calibrator
Establishment type
Manufacture Medical Device
Registration
Registration number
9610126
FEI number
3002806559
Status code
1
Initial importer flag
N
Reg expiry date year
2027
Name
ROCHE DIAGNOSTICS GMBH
Address line 1
SANDHOFER STRASSE 116
City
MANNHEIM Baden-Wurttemberg
Iso country code
DE
Postal code
D-68305
US agent
Name
Brian Frazier
Business name
Roche Diagnostics Operations Inc
Bus phone area code
317
Bus phone num
5214603
Email address
brian.frazier@roche.com
Address line 1
9115 Hague Rd
City
Indianapolis
State code
IN
Iso country code
US
Zip code
46256
Owner operator
Firm name
Roche Diagnostics Operations Inc.
Owner operator number
9039767
Contact address
Address 1
9115 Hague Road
City
Indianapolis
State code
IN
Iso country code
US
Postal code
46250
Products
  1. Product code
    DLJ
    Created date
    2024-02-29
    Owner operator number
    9039767
    Harmonized identifiers (openFDA)
    Device name
    Calibrators, Drug Specific
    Medical specialty description
    Clinical Toxicology
    Regulation number
    862.3200
    Device class
    2
Establishments and listings

LDLC3 LDL-Cholesterol Gen. 3, LDL-C Gen.3, 200Tests, cobas c,Int +4

ROCHE DIAGNOSTICS GMBH · MANNHEIM Baden-Wurttemberg, DE

Repack or Relabel Medical Device +1Reg. 9610126LBR
K number
K143691
Proprietary name
LDLC3 LDL-Cholesterol Gen. 3, LDL-C Gen.3, 200Tests, cobas c,Int, LDL-C Gen.3, 500Tests, cobas c701,702, LDL-C Gen.3, 100Tests, cobas c111, LDL-Cholesterol Gen.3, LDLC3, 600T, cobas c 503
Establishment type
Repack or Relabel Medical Device, Manufacture Medical Device
Registration
Registration number
9610126
FEI number
3002806559
Status code
1
Initial importer flag
N
Reg expiry date year
2027
Name
ROCHE DIAGNOSTICS GMBH
Address line 1
SANDHOFER STRASSE 116
City
MANNHEIM Baden-Wurttemberg
Iso country code
DE
Postal code
D-68305
US agent
Name
Brian Frazier
Business name
Roche Diagnostics Operations Inc
Bus phone area code
317
Bus phone num
5214603
Email address
brian.frazier@roche.com
Address line 1
9115 Hague Rd
City
Indianapolis
State code
IN
Iso country code
US
Zip code
46256
Owner operator
Firm name
Roche Diagnostics Operations Inc.
Owner operator number
9039767
Contact address
Address 1
9115 Hague Road
City
Indianapolis
State code
IN
Iso country code
US
Postal code
46250
Products
  1. Product code
    LBR
    Created date
    2015-08-04
    Owner operator number
    9039767
    Harmonized identifiers (openFDA)
    Device name
    Ldl & Vldl Precipitation, Hdl
    Medical specialty description
    Clinical Chemistry
    Regulation number
    862.1475
    Device class
    1

405 records share this identifier (an establishment lists each device separately); the first 10 are shown.

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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.