FDA.reportPublic FDA data

Retic-Chex Stain

Primary DI
20844509000413
Brand
Retic-Chex Stain
Company
STRECK, INC.
Model
285005
Catalog number
285005
Device description
A buffered and filtered New Methylene Blue that can be used with control and patient samples. Contains 1 vial.
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20844509000413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084450900041320844509000413

GMDN Terms#

Term, Definition table
TermDefinition
New methylene blue solution IVDA new methylene blue (MB) solution intended to be used alone, or in combination with other solutions/stains, for the visualization of biological/clinical specimen tissue structures and/or intra/extracellular elements.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume15Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-228-6090custserv@streck.com

Regulatory Flags#

DUNS number
072915986
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20844509000314Cal-Chex A Plus 2211062211062016-09-16
30844509000311Cal-Chex A Plus 2211072211072016-09-16
40844509000318Cal-Chex A Plus2211082211082016-09-16
20844509000338STaK-Chex Plus Retics2254812254812016-09-19
00844509001379CVA2915042915042016-09-16
00844509001386CVA2917082917082016-09-16
00844509001393CVA2917092917092016-09-16
00844509001409CVA2917102917102016-09-16
00844509001416CVA2917112917112016-09-16
00844509001423CVA2917122917122016-09-16
00844509001430CVA2917132917132016-09-16
00844509001447CVA2917142917142016-09-16
00844509001560CVA for CellDyn 2917152917152016-09-16
00844509001577CVA for CellDyn 2917182917182016-09-16
00844509001584CVA for CellDyn 2917192917192016-09-16
00844509001591CVA for CellDyn 2917202917202016-09-16
00844509001669CVA2917222917222016-09-16
20844509000246Cal-Chex2211012211012016-09-16
30844509000243Cal-Chex 2211032211032016-09-16
10844509000089CD-Chex Plus2133252133252016-09-16