FDA.reportPublic FDA data

Camco

Primary DI
00691573400009
Brand
Camco
Company
CAMBRIDGE DIAGNOSTIC PRODUCTS INC
Model
400
Catalog number
400
Device description
Camco Wright Stain solution for automated and manual staining of blood smears for hematological studies.
Published
2017-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KQCStains, Hematology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQCStains, HematologyHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00691573400009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00691573400009006915734000096915734000090691573400009

GMDN Terms#

Term, Definition table
TermDefinition
Romanowsky stain IVD, kitA collection of chemical agents, dyes, and/or other associated materials referred to as a Romanowsky stain, Giemsa, May-Grünwald, Wright, Leishman, Jenner or Field stain, intended to be used for the demonstration of haematopoietic cells, chromosomes, blood parasites, and/or other blood-based pathogens in biological/clinical specimens.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Gallon

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from heat, sparks and flame. Keep away from sources of ignition. Store in a cool, dry, well-ventilated area away from incompatible substances. Flammables-area. Store tightly closed & upright

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
954-971-4040techinfo@ecamco.com

Regulatory Flags#

DUNS number
069146876
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00691573211032Camco2112112017-03-10
00691573702004Camco7027022017-03-10
00691573702066Camco702-B702-B2017-03-10
00691573702073Camco702-C702-C2017-03-10
00691573100305Camco100310032017-03-29
00691573200005Camco200020002017-03-10
00691573205000Camco2052052017-03-09
00691573210035Camco2102102017-03-10
00691573401006Camco4014012017-03-09
00691573402003Camco 4024022017-03-09
00691573412002Camco4124122017-03-09
00691573700154Camco700-C700-C-12016-06-16
00691573702059Camco702-A702-A2017-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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14719874742918LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)BONRAYBIO CO., LTD.KQC2025-02-16
008171690247673D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKQC2022-12-29
10664369201385STROMATOLYSER-4DSSYSMEX CORPORATIONKQC2022-11-04
80664369201384STROMATOLYSER-4DSSYSMEX CORPORATIONKQC2022-11-04
15099590204143COULTER TruColor Wright StainBeckman Coulter, Inc.KQC2020-08-31
15099590204150COULTER TruColor Wright-Giemsa StainBeckman Coulter, Inc.KQC2020-08-31
15099590204167COULTER TruColor Giemsa StainBeckman Coulter, Inc.KQC2020-08-31
15099590250706COULTER TruColor Wright StainBeckman Coulter, Inc.KQC2020-08-31
15099590250713COULTER TruColor Wright- Giemsa StainBeckman Coulter, Inc.KQC2020-08-31
15099590250720COULTER TruColor Wright Stain Buffer Beckman Coulter, Inc.KQC2020-08-31
15099590250737COULTER TruColor Wright- Giemsa Stain BufferBeckman Coulter, Inc.KQC2020-08-31
15099590250744COULTER TruColor May Grünwald StainBeckman Coulter, Inc.KQC2020-08-31
15099590250751COULTER TruColor Giemsa StainBeckman Coulter, Inc.KQC2020-08-31
00630414976310Diff-Quik™ Solution ISiemens Healthcare Diagnostics Products GmbHKQC2018-09-24
00630414976327Diff-Quik™ Solution IISiemens Healthcare Diagnostics Products GmbHKQC2018-09-24
00630414992617Diff-Quik™ Stain SetSiemens Healthcare Diagnostics Products GmbHKQC2018-09-24
00630414992624Diff-Quik™ FixativeSiemens Healthcare Diagnostics Products GmbHKQC2018-09-24
03760177194519Ral Diff-Quik EZ-Kit (3 x 100ml)R.A.L. DIAGNOSTICSKQC2018-09-07
03760177194526Ral Diff-Quik Kit (3 x 500ml)R.A.L. DIAGNOSTICSKQC2018-09-07
03760177194533Ral Diff-Quik Fixative Solution (1 x 2,5L)R.A.L. DIAGNOSTICSKQC2018-09-07
03760177194540Ral Diff-Quik Solution I (1 x 2,5L)R.A.L. DIAGNOSTICSKQC2018-09-07
03760177194557Ral Diff-Quik Solution II (1 x 2,5L)R.A.L. DIAGNOSTICSKQC2018-09-07
00812117015897FluoroQuench Acridine Orange/Ethidium Bromide - 100mlONE LAMBDA, INC.KQC2018-05-31
00812117016184FluoroQuench Acridine Orange/Ethidium Bromide - 500mlONE LAMBDA, INC.KQC2018-05-31
00812117016207FluoroQuench Acridine Orange/Ethidium Bromide - 2000 mlONE LAMBDA, INC.KQC2018-05-31
00812117018447FluoroQuench Plus Acridine Orange/Ethidium Bromide - 100 mlONE LAMBDA, INC.KQC2018-05-31
00691573200005CamcoCAMBRIDGE DIAGNOSTIC PRODUCTS INCKQC2017-03-10
00691573210035CamcoCAMBRIDGE DIAGNOSTIC PRODUCTS INCKQC2017-03-10
00691573211032CamcoCAMBRIDGE DIAGNOSTIC PRODUCTS INCKQC2017-03-10