FDA.report

Retic-Chex Linearity

Primary DI
00844509001065
Brand
Retic-Chex Linearity
Company
STRECK, INC.
Model
285532
Catalog number
285532
Device description
Retic-Chex Linearity is designed to establish the patient reportable range and linearity of the system. Contains 1 vial each of levels 1-5.
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JPKMixture, Hematology Quality Control

Product Code Classifications

CodeDeviceSpecialtyClass
JPKMixture, Hematology Quality ControlHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00844509001065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00844509001065008445090010658445090010650844509001065

GMDN Terms

TermDefinition
Reticulocyte count IVD, controlA material which is used to verify the performance of an assay that is intended to be used for the qualitative and/or quantitative determination of reticulocyte red blood cells in a clinical specimen.

Device Sizes

TypeValueUnit
Total Volume2.5Milliliter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius10 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-228-6090custserv@streck.com

Regulatory Flags

DUNS number
072915986
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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20844509000130CD-Chex Plus2133652133652016-09-16
20844509000147CD-Chex Plus2133662133662016-09-16
20844509000185Para 12 Plus2189242189242016-09-14
20844509000192Para 12 Plus2189142189142016-09-14
20844509000208Para 12 Plus2189342189342016-09-14
20844509000246Cal-Chex2211012211012016-09-16
20844509000253Cell-Chex2124322124322016-09-16
20844509000260Cell-Chex2124292124292016-09-16
20844509000277Cell-Chex2124242124242016-09-16
20844509000314Cal-Chex A Plus 2211062211062016-09-16

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