International Medical Devices Database

Manufacturer Address
EMD Chemicals Inc, 480 S Democrat Rd, Gibbstown NJ 08027-1239
Source
USFDA
5 Events

5 devices in the database

Device Recall Histochemical PAS (Periodic Acid Schiff) Reaction Set'

Model / Serial
Item number 64945/93; Lot # 8055, Exp. August 31, 2009.
Product Classification
Hematology and Pathology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide.
Product Description
Histochemical PAS (Periodic Acid Schiff) Reaction Set' || Class I, IVD; || Set of 4 bottles including Schiff Reagent 225 mL, Light Green SF Yellowish Stain 225 mL, Sodium Carbonate Solution 225 mL and Periodic Acid Solution 225 mL' || EMD Chemicals, Inc. || 480 S. Democrat Road, || Gibbstown, NJ 08027 || Each kit provides reagents sufficient for a maximum of 100 tests.

Device Recall May and Grunwald's Stain

Model / Serial
Item # 660/75 Lot 7161(1 liter bottle) Item 660/85, Lot 7161(4 liter bottle) Exp. Date: 31 Jan 09
Product Classification
Hematology and Pathology Devices
Device Class
1
Implanted device?
No
Distribution
Product was released to 2 distributors; one in the US, one in Canada
Product Description
Harleco || May and Grunwald's Stain; || 0.17% w/v; || Methanol Solution UN1230; || EMD Chemicals Inc. || An Affilifate of Merck KGaA || Damstadt, Germany; || 480 South Democrat Road; || Gibbstown, NJ 08027; || 1 liter and 4 liter poly bottles

Anaerotest

Model / Serial
Item # 1.15112.0001 Lot # OC553145
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
Product was only sent to one US customer: Becton Dickinson, Cayey. Pureto Rico.
Product Description
Anaerotest;Microbiology , || 50 test strips || 1.15112 || Store dry and tightly closed. || Store at + 15 C to +25C || Merck IVD || 64271 Darmstadt, Germany

Anaerotest

Model / Serial
Item number 1.19034.0002 Lot # OC553145
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
Product was only sent to one US customer: Becton Dickinson, Cayey. Pureto Rico.
Product Description
Anaerotest for microbiology || Specification: Performance Test Anerobic: white within 4-6 hours; aerobic: blue with 20 minutes || Merck KgaA || 64271 Darmstadt, Germany || 1.19034.0002 17.08.06 1 unit || UPC 4 022536 667928

Device Recall Schiff

Model / Serial
Item Number 64945/93 Lot # 5341, Exp. Date: May 31, 2007.
Product Classification
Hematology and Pathology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide.
Product Description
Histochemical PAS (Periodic Acid Schiff) Reaction Set. in vitro diagnostic. Product size configuration: Set of 4 bottles including Schiff Reagent 225mL, Light Green SF Yellowish Stain 225mL, Sodium Carbonate Solution 225mL, and Periodic Acid Solution 225mL. Each kit provides reagents sufficient for a maximum of 100 tests.

3 manufacturers with a similar name

Learn more about the data here

EMD Chemicals Inc

Manufacturer Address
EMD Chemicals Inc, 480 Democrat Road, Gibbstown NJ 08027
Source
USFDA

EMD Chemicals Inc.

Manufacturer Address
EMD Chemicals Inc., 480 S Democrat Rd, Gibbstown NJ 08027-1239
Manufacturer Parent Company (2017)
EMD Chemicals Inc.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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