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FDA-Registered Company Profile for BAYER HEALTHCARE, LLC
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| FDA-Supplied Establishment Information: |
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| Establishment Registration Number: |
1826988 |
| Company Name: |
BAYER HEALTHCARE, LLC |
| Address: |
430 SOUTH BEIGER ST. (Map) |
| Address 2: |
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| City: |
MISHAWAKA |
| State |
IN |
| Zip / Postal Code: |
46544 |
| County: |
ST JOSEPH |
| Country: |
US |
| Establishment Operation Code(s): |
AA - Initial Distributor
MM - Manufacturer
MS - Specification Developer
RR - Repackager/Relabeller
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| Establishment Status Code: |
A -
Active
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Year of Most Recent Initial or Annual Registration: |
2007 |
| FDA-Supplied Owner/Operator Information: |
| Owner/Operator Number: |
2425130 |
| Company Name: |
BAYER HEALTHCARE, LLC
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| Address: |
555 WHITE PLAINS RD. |
| Address 2: |
5TH FLOOR |
| City: |
TARRYTOWN |
| State: |
NY |
| Zip / Postal Code: |
10591 |
| Country: |
US |
| Owner/Operator Phone: |
914-524-2955
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| FDA-Supplied Official Correspondent Information: |
| Official Correspondent Name: |
MR. CHESTER MCCOY |
| Company Name: |
BAYER HEALTHCARE LLC, DIABETES CARE DIVISION |
| Address: |
430 S.BEIGER ST. |
| Address 2: |
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| City: |
MISHAWAKA |
| State: |
IN |
| Zip / Postal Code: |
46544 |
| Country: |
US |
| Official Corespondent Phone Number: |
574-256-3430
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| Other Establishment Information: |
| Establishment Phone: |
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| Fax: |
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| General Email: |
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| Web Site: |
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| Company Brochure: |
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| Keywords: |
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| Company Description: |
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| Services Offered: |
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| About Us: |
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| Differentiation: |
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FDA-Registered Products Offered by BAYER HEALTHCARE, LLC
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Common Device Name |
Proprietary Device Name |
| 1 |
ASSAY, GLYCOSYLATED HEMOGLOBIN |
METRIKA A1CNOW+ |
| 2 |
AUTOMATED URINALYSIS SYSTEM |
CLINILAB AUTOMATED URINALYSIS SYSTEM |
| 3 |
CALIBRATOR |
NO PROPRIETARY NAME LISTED |
| 4 |
CALIBRATOR |
NO PROPRIETARY NAME LISTED |
| 5 |
CALIBRATOR |
NO PROPRIETARY NAME LISTED |
| 6 |
CONTROL MATERIALS |
NO PROPRIETARY NAME LISTED |
| 7 |
CONTROL MATERIALS |
DEX ESPIRIT DEXTER Z CONTROLS |
| 8 |
DATA MANAGEMENT SYSTEMS |
GLUCOFACTS DATA MANAGEMENT SYSTEMS |
| 9 |
DYE AND CLINICAL SOLUTION STAINS |
HEMA-TEK STAIN PAKS |
| 10 |
HEMATOLOGIC SLIDE STAINER |
HEMA-TEK AUTOMATED SLIDE STAINER;HEMA-TEK II AUTOMATED SLIDE STAINER; STAIN PACS |
| 11 |
LANCET, BLOOD |
ASCENSIA MICROLET LANCET |
| 12 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 13 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 14 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
| 15 |
SPECTROPHOTOMETER |
DCA 2000 ANALYZER |
| 16 |
TEST FOR BLOOD GLUCOSE |
GLUCOMETER ENCORE TEST STRIPS |
| 17 |
TEST FOR CANDIDA SPECIES IN VAGINAL SPECIMENS |
MICROSTIX CANDIDA |
| 18 |
TEST FOR ETHOSUXIMIDE IN SERUM OR PLASMA |
NO PROPRIETARY NAME LISTED |
| 19 |
TEST FOR GENTAMICIN IN SERUM OR PLASMA |
NO PROPRIETARY NAME LISTED |
| 20 |
TEST FOR GLUCOSE & KETONES IN URINE |
KETO DIASTIX |
| 21 |
TEST FOR GLUCOSE IN BLOOD |
ASCENSIA ELITE BLOOD GLUCOSE TEST STRIPS |
| 22 |
TEST FOR LEUKOCYTES IN URINE |
LEUKOSTIX REAGENT STRIPS |
| 23 |
TEST FOR LEUKOCYTES,NITRITE,BLOOD,PH,CREATININE,SG,KETONE,PROTEIN LOW/HIGH, |
MULTISTIX PRO 10 LS |
| 24 |
TEST FOR NAPA [N-ACETYLPROCAINAMIDE] TEST KIT |
NO PROPRIETARY NAME LISTED |
| 25 |
TEST FOR NETILMICIN IN SERUM OR PLASMA |
NO PROPRIETARY NAME LISTED |
| 26 |
TEST FOR OCCULT BLOOD IN FECES |
HEMATEST |
| 27 |
TEST FOR PH, PROTEIN, GLUCOSE, KETONE, BILIRUBIN & BLOOD IN URINE |
BILILABSTIX |
| 28 |
TEST FOR PRIMIDONE IN SERUM OR PLASMA |
NO PROPRIETARY NAME LISTED |
| 29 |
TEST FOR PROCAINAMIDE IN SERUM OR PLASMA |
NO PROPRIETARY NAME LISTED |
| 30 |
TEST FOR REDUCING SUGARS IN URINE |
CLINITEST REAGENT TABLETS |
| 31 |
TEST FOR TOBRAMYCIN IN SERUM OR PLASMA |
NO PROPRIETARY NAME LISTED |
| 32 |
TEST FOR UREA NITROGEN IN WHOLE BLOOD |
AZOSTIX |
| 33 |
TEST FOR UROILNOGEN IN URINE |
UROBILISSTIX |
| 34 |
TEST FOR VALPROIC ACID IN SERUM OR PLASMA |
NO PROPRIETARY NAME LISTED |
| 35 |
THREE WAY TEST FOR BACTERIURIA IN URINE |
MICROSTIX-3 |
| 36 |
URINALYSIS CONTROLS |
CHEK-STIX URINALYSIS CONTROLS |
| 37 |
VARIOUS INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) PRODUCTS |
CMBSTIX |
| All FDA-Registered products for this company are displayed above. |
Other Products Offered by BAYER HEALTHCARE, LLC:
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No products have been listed by this company.
Services Offered by the BAYER HEALTHCARE, LLC:
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No services have been listed by this company. |
Additional Contact Information for BAYER HEALTHCARE, LLC:
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| There is no additional contact information for this company. |
Companies Related to BAYER HEALTHCARE, LLC
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Competitors of BAYER HEALTHCARE, LLC
Our records indicate that the following companies may manufacture similar devices.
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