FDA.reportPublic FDA data

S7640 QUALICHECK 7+, level 2 box of 10 ampoules for ABL90 FLEX, ABL90

Primary DI
05700699445216
Brand
S7640 QUALICHECK 7+, level 2 box of 10 ampoules for ABL90 FLEX, ABL90
Company
Radiometer Medical ApS
Model
944-521
Catalog number
944-521
Device description
S7640 QUALICHECK 7+, level 2 box of 10 ampoules for ABL90 FLEX, ABL90 FLEX PLUS
Published
2026-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJYMulti-analyte controls, all kinds (assayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700699445216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700699445216057006994452165700699445216

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+459999999999radiometer@radiometer.dk

Regulatory Flags#

DUNS number
308667539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05700699445193S7620 QUALICHECK 7+, level 0 box of 10 ampoules for ABL90 FLEX, ABL90944-519944-5192026-10-30
05700699445209S7630 QUALICHECK 7+, level 1 box of 10 ampoules for ABL90 FLEX, ABL90944-520944-5202026-10-30
05700699445223S7650 QUALICHECK 7+, level 3 box of 10 ampoules for ABL90 FLEX, ABL90944-522944-5222026-10-30
05700699445230S7660 QUALICHECK 7+, level 4 box of 10 ampoules for ABL90 FLEX, ABL90944-523944-5232026-10-30
05700699058683Membraning kit for tc sensor 54905-868905-8682016-09-01
05700699060259ABL80 CO-OX Capillary adapter906-025906-0252016-09-01
05700699428905SAFE CLINIT. D941P-240-85X1942-890942-8902022-12-05
05700699428929SAFE CLINIT. D957P-70-100X1942-892942-8922022-12-05
05700699428936SAFE CLINIT. D957P-70-125X1942-893942-8932022-12-05
05700699429698safeClinitubes D957P-70-45942-969942-9692022-12-05
05700699058669Electrolyte 54905-866905-8662016-09-01
05700699456052Electrode for ABL analyzers945-605945-6052016-09-01
05700699565259PICO70956-525956-5252016-09-01
05700699565334PICO70956-533956-5332016-09-01
05700699565471PICO70956-547956-5472016-09-01
05700699566089safePICO70956-608956-6082016-09-01
05700699566096safePICO70956-609956-6092016-09-01
05700699566126safePICO70956-612956-6122016-09-01
05700699566133safePICO70956-613956-6132016-09-01
05700699566140safePICO70956-614956-6142016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05700699445193S7620 QUALICHECK 7+, level 0 box of 10 ampoules for ABL90 FLEX, ABL90Radiometer Medical ApSJJY2026-10-30
05700699445209S7630 QUALICHECK 7+, level 1 box of 10 ampoules for ABL90 FLEX, ABL90Radiometer Medical ApSJJY2026-10-30
05700699445223S7650 QUALICHECK 7+, level 3 box of 10 ampoules for ABL90 FLEX, ABL90Radiometer Medical ApSJJY2026-10-30
05700699445230S7660 QUALICHECK 7+, level 4 box of 10 ampoules for ABL90 FLEX, ABL90Radiometer Medical ApSJJY2026-10-30
00850010224497CareSuperb COVID-19 Antigen External ControlAccess Bio Inc.JJY2026-10-01
10673486014112Teco Diagnostics TC-TROL (N) Serum Control Level I HumanTECO DIAGNOSTICSJJY2026-08-25
10673486014129Teco Diagnostics TC-TROL (A) Serum Control Level II HumanTECO DIAGNOSTICSJJY2026-08-25
00850011135556VALIDATELgc Clinical Diagnostics, Inc.JJY2026-07-07
00850011135853ValidateLgc Clinical Diagnostics, Inc.JJY2026-07-07
00850010224459CareSuperb COVID-19/Flu A&B Antigen Combo External ControlAccess Bio Inc.JJY2026-06-08
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05391523442893Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
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05391523442923Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
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